s Eylea » RVO Patient Case Studies

Your Art. Their Vision. 3 Patient Case Studies

Treating Macular Edema following Central Retinal Vein Occlusion (CRVO) With EYLEA® (aflibercept) Injection

Retina Perspectives™s

Clinical Case Studies From the Phase 3 Macular Edema Following CRVO Program

PATIENT 1

Around Mean
  • 62-year-old white male
  • Baseline: 52 ETDRS letters (20/100 Snellen equivalent) and 676 µm CRT
  • Time from CRVO diagnosis >2 months, perfused
  • 24 weeks: +2 ETDRS letters (20/80)

PATIENT 2

Around Mean
  • 84-year-old white male
  • Baseline: 66 ETDRS letters (20/50 Snellen equivalent) and 556 µm CRT
  • Time from CRVO diagnosis >2 months, perfused
  • 24 weeks: +15 ETDRS letters (20/26)

PATIENT 3

Around Mean
  • 53-year-old white female
  • Baseline: 34 ETDRS letters (20/200 Snellen equivalent) and 859 µm CRT
  • Time from CRVO diagnosis ≤2 months, nonperfused
  • 24 weeks: +30 ETDRS letters (20/50)

Jason Slakter, MD

Jason Slakter

The commentary on the anatomic architecture was provided by Jason Slakter, MD. His reading center, Digital Angiography Reading Center (DARC), was one of two reading centers that independently interpreted the anatomic images for all patients in the VIEW 1 trial. In these patient case studies, Dr. Slakter describes the retinal structure at baseline, throughout the course of treatment with EYLEA® (aflibercept) Injection, and at week 52 based on fluorescein angiography (FA), fundus photos, and time domain–optical coherence tomography (TD-OCT) images.

Note: These are case examples that retinal specialists might encounter in clinical practice.

Dr. Slakter was compensated by Regeneron to discuss the clinical data in the patient case studies.

This information reflects the opinion of an individual medical expert and should not be construed as evidence-based guidelines or as Regeneron recommendations. This information is not intended to serve as a substitute for independent medical judgment.

EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration.

EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

In the Wet AMD clinical studies, anatomic measures of disease activity improved similarly in all treatment groups from baseline to week 52. Anatomic data were not used to influence treatment decisions.

Patient 1: Baseline

baseline characteristics
Age
62
Gender
Male
Race
White
Study Eye
Left (OS)
ETDRS* Letters
Snellen Equivalent
52
20/100
CRT (µm)
676
CRVO Diagnosis
>2 months
Perfusion Status
Perfused
baseline characteristics

EARLY FA

LATE FA

fundus photograph

oct
*ETDRS: Early Treatment Diabetic Retinopathy Study.
CRT: central retinal thickness as measured by time domain–optical coherence tomography (TD-OCT).
Ocular History

None reported

Medical History

Hypertension, hypercholesterolemia, hypothyroidism, GERD, osteoarthritis,
appendicitis followed by appendectomy, cartilage injury followed by knee operation

BASELINE CONCOMITANT MEDICATIONS

Lisinopril, atorvastatin, levothyroxine, famotidine

“The patient in Case 1 shows extensive hemorrhages throughout the posterior pole which are visible on the fundus photo. The fluorescein angiography (FA) shows marked hyperfluorescence of the optic nerve early with late staining indicating a marked congestion of the peripapillary vessels. There is some staining of the larger retinal vessels and mild leakage in the central macular area on the late fluorescein angiogram. The OCT shows both cystic edema of the retina as well as subfoveal, subretinal fluid. This patient also has a history of hypertension which is a known risk factor for CRVO.”

All commentary is provided by Jason Slakter, MD. View Jason Slakter, MD’s bio

SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

  • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
  • There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months. The incidence of ATEs in the VISTA and VIVID DME studies during the first year was 3.3% in the combined group of patients treated with EYLEA compared with 2.8% in the control group.

Treatment Progress

Baseline
▲ from BL
BCVA (ETDRS)
52
NA
Snellen Equivalent
20/100
CRT
676-µm
NA

“The OCT shows both cystic edema of the retina as well as subfoveal, subretinal fluid.”

All commentary is provided by Jason Slakter, MD.
Week 4
▲ from BL
BCVA (ETDRS)
60
+8
Snellen Equivalent
20/60
CRT
192-µm
-484

“Compared to baseline, by week 4 there is a normalization of the retinal edema and subretinal fluid. An improvement in vision is seen in the patient over the same time period.”

All commentary is provided by Jason Slakter, MD.
Week 12
▲ from BL
BCVA (ETDRS)
57
+5
Snellen Equivalent
20/80
CRT
229-µm
-447

“By the week-12 visit, the retina appears stable but the patient experienced a decrease in visual acuity from week 4.”

All commentary is provided by Jason Slakter, MD.
Week 24
▲ from BL
BCVA (ETDRS)
54
+2
Snellen Equivalent
20/80
CRT
221-µm
-465

“By week 24, the patient’s vision has declined further in spite of the retina remaining dry.”

All commentary is provided by Jason Slakter, MD.

SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

  • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
  • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.

    Results at 24 weeks

    Early FA
    Week 24
    Late FA
    Week 24
    Fundus Photograph
    Week 24
    Oct
    Week 24

    SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

    • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
    • There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months. The incidence of ATEs in the VISTA and VIVID DME studies during the first year was 3.3% in the combined group of patients treated with EYLEA compared with 2.8% in the control group.

    Summary

    Baseline characteristics


    ETDRS Letters
    52
    Snellen Equivalent
    20/100
    CRT (µm)
    676
    Perfusion Status
    Perfused
    Week 24
    ▲ from
    BL
    ETDRS Letters
    54
    +2
    Snellen Equivalent
    20/80
    CRT (µm)
    211
    -465
    Perfusion Status
    Perfused
    None
    Summary
    Study Eye Ocular Adverse Events
    Outcome
    none reported
    not applicable
    Non-ocular Adverse Events
    Outcome
    protein urine present,
    urine ketone body present
    not specified
    Additional Concomitant Medications
    During Study Period
    none reported

    “Week-24 images compared to baseline visit show reduction in the degree of leakage in the macular region as well as over the optic nerve and resolution of the retinal edema and subretinal fluid on OCT. However, mean BCVA only improved by 2 letters from baseline. Although this patient is relatively young, the more chronic duration of the disease and resulting structural retinal changes may have contributed to the final visual outcome. Note that protein and a ketone body were present in the patient’s urine at the baseline visit.”

    All commentary is provided by Jason Slakter, MD.

    SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

    • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.
    • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, retinal detachment, cataract, intraocular pressure increased, and vitreous detachment.
    Baseline
    EARLY FA
    Baseline
    LATE FA
    Baseline
    Fundus Photograph
    Baseline
    OCT
    Baseline
    Week 4
    Week 12
    Week 24
    Early FA
    Baseline
    Week 24
    Late FA
    Baseline
    Week 24
    Fundus Photograph
    Baseline
    Week 24
    OCT
    Baseline
    Week 24

    Jason Slakter, MD

    Jason Slakter

    The commentary on the anatomic architecture was provided by Jason Slakter, MD. His reading center, Digital Angiography Reading Center (DARC), was one of two reading centers that independently interpreted the anatomic images for all patients in the VIEW 1 trial. In these patient case studies, Dr. Slakter describes the retinal structure at baseline, throughout the course of treatment with EYLEA® (aflibercept) Injection, and at week 52 based on fluorescein angiography (FA), fundus photos, and time domain–optical coherence tomography (TD-OCT) images.

    Note: These are case examples that retinal specialists might encounter in clinical practice.

    Dr. Slakter was compensated by Regeneron to discuss the clinical data in the patient case studies.

    This information reflects the opinion of an individual medical expert and should not be construed as evidence-based guidelines or as Regeneron recommendations. This information is not intended to serve as a substitute for independent medical judgment.

    EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration.

    EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

    In the Wet AMD clinical studies, anatomic measures of disease activity improved similarly in all treatment groups from baseline to week 52. Anatomic data were not used to influence treatment decisions.

    Patient 2: Baseline

    baseline characteristics
    Age
    84
    Gender
    Male
    Race
    White
    Study Eye
    Left (OS)
    ETDRS* Letters
    Snellen Equivalent
    66
    20/50
    CRT (µm)
    556
    Perfusion Status
    Perfused
    baseline characteristics

    EARLY FA

    LATE FA

    fundus photograph

    oct
    *ETDRS: Early Treatment Diabetic Retinopathy Study.
    CRT: central retinal thickness as measured by time domain–optical coherence tomography (TD-OCT).
    Ocular History

    Both eyes: cataract surgery, glaucoma, vitreous detachment

    Medical History

    Dyslipidemia, atrial fibrillation, pulmonary embolism, deep vein thrombosis, benign prostatic hyperplasia,
    depression, infective cholecystitis followed by cholecystectomy, inguinal hernia followed by repair

    BASELINE CONCOMITANT MEDICATIONS

    Brimonidine ophthalmic, brinzolamide ophthalmic, lovastatin, metoprolol, doxazosin, warfarin, drugs used in
    benign prostatic hypertrophy, citalopram, aspirin

    “Early FA for the patient in Case 2 shows good vascular perfusion and minimal blockage from focal blood. The late FA shows marked leakage around the fovea and temporally. The OCT shows edema in the central macula with a large inner retinal cyst and some focal central subretinal fluid. The age of the patient and the large foveal cyst suggest that the visual outcome of therapy may be limited. The patient has a history of glaucoma, a risk factor for vein occlusion. He was also taking both aspirin and warfarin at the time of the occlusion.”

    All commentary is provided by Jason Slakter, MD. View Jason Slakter, MD’s bio

    SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

    • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
    • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.

    Treatment Progress

    Baseline
    ▲ from BL
    BCVA (ETDRS)
    66
    NA
    Snellen Equivalent
    20/50
    CRT
    556-µm
    NA

    “The OCT shows edema in the central macula with a large inner retinal cyst and some focal central subretinal fluid.”

    All commentary is provided by Jason Slakter, MD.
    Week 4
    ▲ from BL
    BCVA (ETDRS)
    75
    +9
    Snellen Equivalent
    20/32
    CRT
    200-µm
    -356

    “Compared to the baseline, by week 4 there is resolution of the retinal edema and subretinal fluid. As can be seen on the OCT, the inner retinal cyst has completely resolved as well. A 9-letter improvement in vision is seen during the same time period.”

    All commentary is provided by Jason Slakter, MD.
    Week 12
    ▲ from BL
    BCVA (ETDRS)
    83
    +17
    Snellen Equivalent
    20/26
    CRT
    215-µm
    -341

    “By the week-12 visit, the retina appears stable with an improvement in visual acuity since week 4.”

    All commentary is provided by Jason Slakter, MD.
    Week 24
    ▲ from BL
    BCVA (ETDRS)
    81
    +15
    Snellen Equivalent
    20/26
    CRT
    212-µm
    -344

    “By week 24, the vision has stabilized with the retina remaining dry. Note the central foveal retina appears normal in thickness in spite of the large cyst observed at baseline.”

    All commentary is provided by Jason Slakter, MD.

    SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

    • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.
    • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, retinal detachment, cataract, intraocular pressure increased, and vitreous detachment.

      Results at 24 weeks

      Early FA
      Week 24
      Late FA
      Week 24
      Fundus Photograph
      Week 24
      Oct
      Week 24

      SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

      • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
      • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.

      Summary

      Baseline characteristics


      ETDRS Letters
      66
      Snellen Equivalent
      20/50
      CRT (µm)
      556
      Perfusion Status
      Perfused
      Week 24
      ▲ from
      BL
      ETDRS Letters
      81
      +15
      Snellen Equivalent
      20/26
      CRT (µm)
      212
      -344
      Perfusion Status
      Perfused
      None
      Summary
      Study Eye Ocular Adverse Events
      Outcome
      optic nerve cup/disc ratio increase
      not specified
      Non-ocular Adverse Events
      Outcome
      none reported
      not applicable
      Additional Concomitant Medications
      During Study Period
      none reported

      “Week-24 images compared to those from baseline show reduction of the leakage in the macular region and resolution of the retinal edema and subretinal fluid on OCT. Note that at week 12, the patient presented with an increase in the optic nerve cup/disc ratio in the right eye. The following month, there was an increase present in both eyes. This case illustrates that even with an older patient with foveal cystic changes, an improvement in vision is still possible.”

      All commentary is provided by Jason Slakter, MD.

      SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

      • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
      • There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months. The incidence of ATEs in the VISTA and VIVID DME studies during the first year was 3.3% in the combined group of patients treated with EYLEA compared with 2.8% in the control group.
      Baseline
      EARLY FA
      Baseline
      LATE FA
      Baseline
      Fundus Photograph
      Baseline
      OCT
      Baseline
      Week 4
      Week 12
      Week 24
      Early FA
      Baseline
      Week 24
      Late FA
      Baseline
      Week 24
      Fundus Photograph
      Baseline
      Week 24
      OCT
      Baseline
      Week 24

      Jason Slakter, MD

      Jason Slakter

      The commentary on the anatomic architecture was provided by Jason Slakter, MD. His reading center, Digital Angiography Reading Center (DARC), was one of two reading centers that independently interpreted the anatomic images for all patients in the VIEW 1 trial. In these patient case studies, Dr. Slakter describes the retinal structure at baseline, throughout the course of treatment with EYLEA® (aflibercept) Injection, and at week 52 based on fluorescein angiography (FA), fundus photos, and time domain–optical coherence tomography (TD-OCT) images.

      Note: These are case examples that retinal specialists might encounter in clinical practice.

      Dr. Slakter was compensated by Regeneron to discuss the clinical data in the patient case studies.

      This information reflects the opinion of an individual medical expert and should not be construed as evidence-based guidelines or as Regeneron recommendations. This information is not intended to serve as a substitute for independent medical judgment.

      EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration.

      EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

      In the Wet AMD clinical studies, anatomic measures of disease activity improved similarly in all treatment groups from baseline to week 52. Anatomic data were not used to influence treatment decisions.

      Patient 3: Baseline

      baseline characteristics
      Age
      53
      Gender
      Male
      Race
      White
      Study Eye
      Left (OS)
      ETDRS* Letters
      Snellen Equivalent
      34
      20/200
      CRT (µm)
      859
      CRVO Diagnosis
      ≤2 months
      Perfusion Status
      Nonperfused
      baseline characteristics

      EARLY FA

      LATE FA

      fundus photograph

      oct
      *ETDRS: Early Treatment Diabetic Retinopathy Study.
      CRT: central retinal thickness as measured by time domain–optical coherence tomography (TD-OCT).
      Ocular History

      Study eye: choroidal nevus, argon laser trabeculoplasty
      Study eye: pterygium
      Both eyes: cataract

      Medical History

      Type 2 diabetes mellitus, hypercholesterolemia, hypertension, postmenopause

      BASELINE CONCOMITANT MEDICATIONS

      Ketotifen ophthalmic, ocular lubricant, quinapril, aspirin, glipizide, atorvastatin

      “Note the extent of nonperfusion and the massive leakage and cystic changes in Case 3. Early FA shows a temporal area of vascular nonperfusion and focal blockage from blood. Late FA shows significant leakage throughout the macular area and persistent evidence of nonperfusion temporally. The OCT shows extensive edema involving the central macula with larger inner retinal cystic changes and subretinal fluid (with some internal reflectivity suggesting possible blood or debris).

      There is a history of hypertension. She was taking aspirin at the time of the vascular event.”

      All commentary is provided by Jason Slakter, MD. View Jason Slakter, MD’s bio

      SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

      • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.
      • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, retinal detachment, cataract, intraocular pressure increased, and vitreous detachment.

      Treatment Progress

      Baseline
      ▲ from BL
      BCVA (ETDRS)
      34
      NA
      Snellen Equivalent
      20/200
      CRT
      859-µm
      NA

      “The OCT shows extensive edema involving the central macula with larger inner retinal cystic changes and subretinal fluid (with some internal reflectivity suggesting possible blood or debris).”

      All commentary is provided by Jason Slakter, MD.
      Week 4
      ▲ from BL
      BCVA (ETDRS)
      52
      +18
      Snellen Equivalent
      20/100
      CRT
      282-µm
      -577

      “Compared to baseline, by the week-4 visit there is a reduction in both the retinal edema and subretinal fluid. As can be seen on the OCT, the inner retinal cysts are still present but some shallow subretinal fluid persists. In spite of the residual fluid, improvement in vision is already apparent.”

      All commentary is provided by Jason Slakter, MD.
      Week 12
      ▲ from BL
      BCVA (ETDRS)
      60
      +30
      Snellen Equivalent
      20/50
      CRT
      190-µm
      -669

      “By the week-12 visit, the retina has flattened further with resolution of the retinal cysts and subretinal fluid. There is a further improvement in visual acuity since week 4.”

      All commentary is provided by Jason Slakter, MD.
      Week 24
      ▲ from BL
      BCVA (ETDRS)
      64
      +30
      Snellen Equivalent
      20/50
      CRT
      185-µm
      -674

      “By week 24, the patient’s vision has stabilized with the retina now appearing totally dry and a 30-letter improvement.”

      All commentary is provided by Jason Slakter, MD.

      SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

      • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
      • There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months. The incidence of ATEs in the VISTA and VIVID DME studies during the first year was 3.3% in the combined group of patients treated with EYLEA compared with 2.8% in the control group.

        Results at 24 weeks

        Early FA
        Week 24
        Late FA
        Week 24
        Fundus Photograph
        Week 24
        Oct
        Week 24

        SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

        • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.
        • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, retinal detachment, cataract, intraocular pressure increased, and vitreous detachment.

        Summary

        Baseline characteristics


        ETDRS Letters
        34
        Snellen Equivalent
        20/200
        CRT (µm)
        859
        Perfusion Status
        Nonperfused
        Week 24
        ▲ from
        BL
        ETDRS Letters
        64
        +30
        Snellen Equivalent
        20/50
        CRT (µm)
        185
        -674
        Perfusion Status
        Nonperfused
        None
        Summary
        Study Eye Ocular Adverse Events
        Outcome
        none reported
        not applicable
        Non-ocular Adverse Events
        Outcome
        none reported
        not applicable
        Additional Concomitant Medications
        During Study Period
        none reported

        “Week-24 images compared to baseline show reduction in retinal hemorrhage, a resolution of the leakage in the macular region, and resolution of the retinal edema and subretinal fluid on OCT. There is some lipid precipitated in the perifoveal and temporal region. This case illustrates that even with significant nonperfusion outside the macular region and extensive leakage with retinal cysts, improvement in vision is possible.”

        All commentary is provided by Jason Slakter, MD.

        SELECT IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

        • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
        • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
        Baseline
        EARLY FA
        Baseline
        LATE FA
        Baseline
        Fundus Photograph
        Baseline
        OCT
        Baseline
        Week 4
        Week 12
        Week 24
        Early FA
        Baseline
        Week 24
        Late FA
        Baseline
        Week 24
        Fundus Photograph
        Baseline
        Week 24
        OCT
        Baseline
        Week 24

        Jason Slakter, MD

        The commentary on the anatomic architecture was provided by jason Slakter, MD. His reading center, Digital Angiography Reading Center (DARC), was one of two reading centers that independently interpreted thea atomic images for all patients in the VIEW 1 trial. In these patient case studies, Dr. Slakter describes the retinal structure at baseline, throughout the course of treatment with EYLEA® (aflibercept) Injection, and at week 52 based on fluorescein angiography (FA), funds photos, and time domain-optical coherence tomography (TD-OCT) images.

        Note: These are case examples that retinal specialists might encounter in clinical practice.

        Dr. Slakter was compensated by Regeneron to discuss the clinical data in the patient case studies.

        This information reflects the opinion of an individual medical expert and should not be construed as evidence-based guidelines or as Regeneron recommendations. THis information is not intended to serve as a substitute for independent medical judgment.

        EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration.

        EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

        In the Wet AMD clinical studies, anatomic measures of disease activity improved similarity in all treatment groups from baseline to week 52. Anatomic data were not used to influence treatment decisions.

        Coming Soon

        IMPORTANT SAFETY INFORMATION
        +
        • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
        • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
        • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
        • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.
        • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
        • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment.
        IMPORTANT PRESCRIBING INFORMATION

        EYLEA® (aflibercept) Injection is indicated for the treatment of patients with

        • Neovascular (Wet) Age-related Macular Degeneration (AMD): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
        • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly).
        • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with DME: The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).

        Please see the full Prescribing Information for EYLEA.

        You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

        The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

        EYLEA and EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.

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