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Your Art. Their Vision. 4 Patient Case Studies

Treating Wet Age-related Macular Degeneration (Wet AMD) Patients With EYLEA® (aflibercept) Injection

Retina Perspectives™

Clinical Case Studies From the Phase 3 Wet AMD Program

PATIENT 1

  • 88-year-old white female
  • Baseline: 47 ETDRS letters (20/126 Snellen equivalent) and 432 µm CRT
  • Large, minimally classic lesion with active CNV area of 14.86 mm2
  • 52 weeks: +8 ETDRS letters (20/80)

PATIENT 2

  • 78-year-old white female
  • Baseline: 50 ETDRS letters (20/100 Snellen equivalent) and 476 µm CRT
  • Classic lesion with active CNV area of 1.4 mm2
  • 52 weeks: +20 ETDRS letters (20/40)

PATIENT 3

  • 83-year-old white male
  • Baseline: 51 ETDRS letters (20/100 Snellen equivalent) and 322 µm CRT
  • Classic lesion with active CNV area of 1.19 mm2
  • 52 weeks: +3 ETDRS letters (20/80)

PATIENT 4

  • 58-year-old white female
  • Baseline: 60 ETDRS letters (20/64 Snellen equivalent) and 284 µm CRT
  • Classic and occult lesion with active CNV area of 12.26 mm2
  • 52 weeks: -5 ETDRS letters (20/80)

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
88
Gender
Female
Race
White
Study Eye
Right (OD)
ETDRS* Letters
Snellen Equivalent
47
20/126
CRT (µm)
432
Lesion Type
Classic and Occult
Total Lesion Size (mm2)
14.86
Active CNV (mm2)
14.86
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).
CNV: choroidal neovascularization.
Ocular History

Fellow eye: dry AMD, macular drusen, granular retinal pigment epithelium
Both eyes: peripheral cystoid in retina non-macular, posterior vitreous detachment, tilted disc, cataract surgery

Medical History

High cholesterol, hypertension, carotid artery stenosis, left anterior hemiblock, postmenopausal, overactive bladder, melanoma, bilateral total knee replacement, varicose vein surgery repair, surgical removal of mass on neck

BASELINE CONCOMITANT MEDICATIONS

Aspirin, oxybutynin, atorvastatin, ezetimibe, AREDS formulation supplement

“The patient in Case 1 is an 88-year-old white female with wet AMD with a starting visual acuity of 47 letters on the ETDRS chart or a Snellen equivalent of 20/126 and central retinal thickness of 432 µm at baseline. The patient had a large, minimally classic lesion with an active CNV area of 14.86 mm2.

Baseline FA images showed well-defined classic CNV and surrounding larger and occult CNV.”

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

Treatment Progress

Baseline
▲ from BL
BCVA (ETDRS)
47
NA
Snellen Equivalent
20/126
CRT
432 µm
NA

“The OCT at baseline showed a thickened retina with edema and a CRT of 432 µm.”

All commentary is provided by Jason Slakter, MD.
Week 4
▲ from BL
BCVA (ETDRS)
33
-14
Snellen Equivalent
20/250
CRT
293 µm
-139

“The patient had an initial decrease in visual acuity at week 4 while the CRT decreased.”

All commentary is provided by Jason Slakter, MD.
Week 12
▲ from BL
BCVA (ETDRS)
51
+4
Snellen Equivalent
20/100
CRT
189 µm
-243

“While continuing the treatment protocol, we see at week 12 the patient gained 4 letters and continued to show a decrease in CRT.”

All commentary is provided by Jason Slakter, MD.
Week 52
▲ from BL
BCVA (ETDRS)
55
+8
Snellen Equivalent
20/80
CRT
181 µm
-251

“At week 52, this patient gained 8 ETDRS letters vs baseline and demonstrated an anatomic reduction in fluid by 251 µm on OCT.”

All commentary is provided by Jason Slakter, MD.

    Results at 52 weeks

    Early FA
    Week 52
    Late FA
    Week 52
    Fundus Photograph
    Week 52
    Oct
    Week 52

    Summary

    Baseline characteristics


    ETDRS Letters
    47
    Snellen Equivalent
    20/126
    CRT (µm)
    432
    Total Lesion Size (mm2)
    14.86
    Active CNV (mm2)
    14.86
    Week 52
    ▲ from
    BL
    ETDRS Letters
    55
    +8
    Snellen Equivalent
    20/80
    +8
    CRT (µm)
    181
    -251
    Total Lesion Size (mm2)
    1.94
    -12.92
    Active CNV (mm2)
    0
    -14.86
    Study Eye Ocular Adverse Events
    Outcome
    RPE tear
    recovered
    RPE changes
    ongoing
    Non-ocular Adverse Events
    Outcome
    degenerative joint disease
    ongoing
    vertigo
    recovered
    worsening of intimal thickening of
    right internal carotid artery
    ongoing
    Additional Concomitant Medications
    During Study Period
    meclizine, candesartan HCT

    “At week 52, we see that there was a reduction in the active area of CNV to zero with resolution of fluid on OCT. Compared to baseline, this patient achieved an 8-letter gain in visual acuity and a 251-µm reduction in CRT consistent with the overall findings of the VIEW 1 study. The adverse events in the study eye during the trial period were an RPE tear at week 20 and RPE changes. The patient also experienced some non-ocular adverse events.”

    All commentary is provided by Jason Slakter, MD.
    Baseline
    EARLY FA
    Baseline
    LATE FA
    Baseline
    Fundus Photograph
    Baseline
    OCT
    Baseline
    Week 4
    Week 12
    Week 52
    Early FA
    Baseline
    Week 52
    Late FA
    Baseline
    Week 52
    Fundus Photograph
    Baseline
    Week 52
    OCT
    Baseline
    Week 52

    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
    78
    Gender
    Female
    Race
    White
    Study Eye
    Right (OD)
    ETDRS* Letters
    Snellen Equivalent
    50
    20/100
    CRT (µm)
    476
    Lesion Type
    Classic
    Total Lesion Size (mm2)
    1.4
    Active CNV (mm2)
    1.4
    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).
    CNV: choroidal neovascularization.
    Ocular History

    Study eye: cataract surgery, posterior vitreous detachment
    Fellow eye: narrow anterior chamber angle, YAG laser iridotomy, cataract

    Medical History

    Breast cancer followed by mastectomy, cholecystectomy, C-section (3), postmenopausal

    BASELINE CONCOMITANT MEDICATIONS

    Anastrozole, aspirin, multivitamin, calcium, zoledronic acid, AREDS formulation supplement

    “The patient in Case 2 is a 78-year-old white female with wet AMD with a starting visual acuity of 50 letters on the ETDRS chart or a Snellen equivalent of 20/100 and central retinal thickness of 476 µm at baseline. The patient had a classic lesion measuring 1.4 mm2.

    At baseline, there was a classic membrane that was actively leaking. Retinal edema was seen on the OCT, and there was minimal fibrovascular tissue at baseline. The OCT depicts the CRT at 476 µm.”

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

    Treatment Progress

    Baseline
    ▲ from BL
    BCVA (ETDRS)
    50
    NA
    Snellen Equivalent
    20/100
    CRT
    476 µm
    NA

    “The OCT at baseline demonstrates centrally located retinal edema and localized subretinal fluid.”

    All commentary is provided by Jason Slakter, MD.
    Week 4
    ▲ from BL
    BCVA (ETDRS)
    66
    +16
    Snellen Equivalent
    20/50
    CRT
    270 µm
    -206

    “By week 4, there is total resolution of the subretinal fluid, and the cystic changes in the retina are no longer visible. There may still be some thickening centrally. However, vision has improved.”

    All commentary is provided by Jason Slakter, MD.
    Week 12
    ▲ from BL
    BCVA (ETDRS)
    55
    +5
    Snellen Equivalent
    20/80
    CRT
    252 µm
    -224

    “By week 12, there is less retinal thickening with no recurrence of edema or subretinal fluid. However, there is a visual decline at this visit.”

    All commentary is provided by Jason Slakter, MD.
    Week 52
    ▲ from BL
    BCVA (ETDRS)
    70
    +20
    Snellen Equivalent
    20/40
    CRT
    183 µm
    -293

    “At week 52, there is now a visible foveal depression indicating total resolution of the exudation, along with a marked improvement in vision.”

    All commentary is provided by Jason Slakter, MD.

      Results at 52 weeks

      Early FA
      Week 52
      Late FA
      Week 52
      Fundus Photograph
      Week 52
      Oct
      Week 52

      Summary

      Baseline characteristics


      ETDRS Letters
      50
      Snellen Equivalent
      20/100
      CRT (µm)
      476
      Total Lesion Size (mm2)
      1.4
      Active CNV (mm2)
      1.4
      Week 52
      ▲ from
      BL
      ETDRS Letters
      70
      +20
      Snellen Equivalent
      20/40
      CRT (µm)
      183
      -293
      Total Lesion Size (mm2)
      1.54
      +0.14
      Active CNV (mm2)
      1.12
      -0.28
      Study Eye Ocular Adverse Events
      Outcome
      retinoschisis
      ongoing
      subconjunctival hemorrhage
      recovered
      Non-ocular Adverse Events
      Outcome
      none reported
      not applicable
      vertigo
      recovered
      Additional Concomitant Medications
      During Study Period
      none reported

      “Week-52 images showed a reduced total lesion size based on clinical appearance with a small amount of occult leakage. There was still a little fluid at the temporal edge seen on OCT, but the patient improved from baseline. The baseline and week-52 results show a BCVA improvement of 20 ETDRS letters with a decrease in CRT and leakage on the FA. Adverse events in the study eye during the trial period were retinoschisis and subconjunctival hemorrhage.”

      All commentary is provided by Jason Slakter, MD.
      Baseline
      EARLY FA
      Baseline
      LATE FA
      Baseline
      Fundus Photograph
      Baseline
      OCT
      Baseline
      Week 4
      Week 12
      Week 52
      Early FA
      Baseline
      Week 52
      Late FA
      Baseline
      Week 52
      Fundus Photograph
      Baseline
      Week 52
      OCT
      Baseline
      Week 52

      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
      83
      Gender
      Male
      Race
      White
      Study Eye
      Right (OD)
      ETDRS* Letters
      Snellen Equivalent
      51
      20/100
      CRT (µm)
      322
      Lesion Type
      Classic
      Total Lesion Size (mm2)
      1.19
      Active CNV (mm2)
      1.19
      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).
      CNV: choroidal neovascularization.
      Ocular History

      Study eye: choroidal nevus, argon laser trabeculoplasty
      Fellow eye: pigment changes
      Both eyes: dry AMD, macular drusen, fine epiretinal membrane, glaucoma, peripapillary atrophy, cataract surgery

      Medical History

      Hypertension, hyperlipidemia, coronary artery disease, arrhythmia, implanted pacemaker, angina pectoris, right bundle branch block, anterolateral and inferior infarct on ECG, carotid endarterectomy, osteoarthritis, colon cancer followed by surgery, gout, hearing loss

      BASELINE CONCOMITANT MEDICATIONS

      Latanoprost ophthalmic solution, warfarin, losartan, aspirin, hydrochlorothiazide, nitroglycerin, potassium, verapamil, simvastatin, methylsulfonylmethane and glucosamine

      “The patient in Case 3 is an 83-year-old white male with wet AMD with a starting visual acuity of 51 letters on the ETDRS chart or a Snellen equivalent of 20/100 and a central retinal thickness of 322 µm at baseline. The patient had a small, classic lesion measuring 1.19 mm2 that was composed entirely of active CNV with an area also equal to 1.19 mm2.

      At baseline, the early FA shows the active classic component that leaked extensively in the late phase. The fundus photo showed some RPE atrophic changes, and the OCT demonstrated leakage under the central macula with fibrovascular tissue beneath.”

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

      Treatment Progress

      Baseline
      ▲ from BL
      BCVA (ETDRS)
      51
      NA
      Snellen Equivalent
      20/100
      CRT
      322 µm
      NA

      “The OCT at baseline demonstrates subretinal fluid and what appears to be subretinal fibrovascular tissue.”

      All commentary is provided by Jason Slakter, MD.
      Week 4
      ▲ from BL
      BCVA (ETDRS)
      52
      +1
      Snellen Equivalent
      20/100
      CRT
      252 µm
      -70

      “By week 4, there is a reduction in the subretinal fluid with no significant change in vision.”

      All commentary is provided by Jason Slakter, MD.
      Week 12
      ▲ from BL
      BCVA (ETDRS)
      57
      +6
      Snellen Equivalent
      20/80
      CRT
      252 µm
      -70

      “By week 12, there is no longer any visible subretinal fluid. There is an associated improvement in vision.”

      All commentary is provided by Jason Slakter, MD.
      Week 52
      ▲ from BL
      BCVA (ETDRS)
      54
      +3
      Snellen Equivalent
      20/80
      CRT
      192 µm
      -130

      “At week 52, there is now a reduction in the subretinal fibrovascular tissue and a slight improvement in vision from baseline.”

      All commentary is provided by Jason Slakter, MD.

        Results at 52 weeks

        Early FA
        Week 52
        Late FA
        Week 52
        Fundus Photograph
        Week 52
        Oct
        Week 52

        Summary

        Baseline characteristics


        ETDRS Letters
        51
        Snellen Equivalent
        20/100
        CRT (µm)
        322
        Total Lesion Size (mm2)
        1.19
        Active CNV (mm2)
        1.19
        Week 52
        ▲ from
        BL
        ETDRS Letters
        54
        +3
        Snellen Equivalent
        20/80
        CRT (µm)
        192
        -130
        Total Lesion Size (mm2)
        4.56
        +3.37
        Active CNV (mm2)
        0
        -1.19
        Study Eye Ocular Adverse Events
        Outcome
        subconjunctival hemorrhage
        recovered
        vitreous syneresis
        ongoing
        Non-ocular Adverse Events
        Outcome
        skin fungus (palms and feet)
        recovered
        Additional Concomitant Medications
        During Study Period
        ciclopirox gel, desoximetasone

        “The FA, fundus photo, and OCT at week 52 confirm the presence of relatively inactive subfoveal fibrovascular scarring, which may or may not have contributed to a limited gain in visual acuity vs baseline. Comparing week-52 results to baseline, we see a marked reduction in anatomic measures, but visual acuity gains are limited to 3 letters of BCVA on an ETDRS chart. The ocular adverse events in the study eye during the trial period included subconjunctival hemorrhage and vitre.”

        All commentary is provided by Jason Slakter, MD.
        Baseline
        EARLY FA
        Baseline
        LATE FA
        Baseline
        Fundus Photograph
        Baseline
        OCT
        Baseline
        Week 4
        Week 12
        Week 52
        Early FA
        Baseline
        Week 52
        Late FA
        Baseline
        Week 52
        Fundus Photograph
        Baseline
        Week 52
        OCT
        Baseline
        Week 52

        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 4: Baseline

        baseline characteristics
        Age
        58
        Gender
        Female
        Race
        White
        Study Eye
        Right (OD)
        ETDRS* Letters
        Snellen Equivalent
        60
        20/64
        CRT (µm)
        284
        Lesion Type
        Classic and Occult
        Total Lesion Size (mm2)
        12.26
        Active CNV (mm2)
        12.06
        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).
        CNV: choroidal neovascularization.
        Ocular History

        Fellow eye: dry AMD, macular drusen
        Both eyes: cataract

        Medical History

        Hypertension, asthma, osteoarthritis, tubal ligation

        BASELINE CONCOMITANT MEDICATIONS

        Nifedipine, hydrochlorothiazide, lisinopril, fluticasone propionate oral inhalation, salbutamol acetaminophen

        “This patient had a mixed classic and occult CNV at baseline. The FA shows an area of active classic CNV on the nasal edge of the lesion with more occult, fibrovascular tissue under the central foveal region. There are areas of relative hypofluorescence and hyperfluorescence at baseline. The color photo shows hemorrhage along the nasal edge corresponding to the active classic CNV. There is some gravitating lipid inferiorly. The baseline OCT shows retinal edema and subretinal fluid.”

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

        Treatment Progress

        Baseline
        ▲ from BL
        BCVA (ETDRS)
        60
        NA
        Snellen Equivalent
        20/64
        CRT
        284 µm
        NA

        “The OCT images at baseline show retinal edema, subretinal fluid (mainly on the nasal side where most active CNV is located), and some possible loss of RPE.”

        All commentary is provided by Jason Slakter, MD.
        Week 4
        ▲ from BL
        BCVA (ETDRS)
        65
        +5
        Snellen Equivalent
        20/50
        CRT
        183 µm
        -101

        “At week 4, there is resolution of the edema and subretinal fluid, but some trace fluid may be present nasally. A slight increase in RPE signal in the subfoveal region suggests possible thin fibrovascular tissue being present.”

        All commentary is provided by Jason Slakter, MD.
        Week 12
        ▲ from BL
        BCVA (ETDRS)
        69
        +9
        Snellen Equivalent
        20/40
        CRT
        182 µm
        -102

        “At week 12, there is some thinning of the retina in the foveal region with some cystic-like spaces present on the images.”

        All commentary is provided by Jason Slakter, MD.
        Week 52
        ▲ from BL
        BCVA (ETDRS)
        55
        -5
        Snellen Equivalent
        20/80
        CRT
        188 µm
        -96

        “By week 52, there are still some inner and outer retinal cystic changes. Note on the right that there appears to be some disruption of the retinal layer above the thickened RPE/fibrovascular tissue that may account for the drop in vision.”

        All commentary is provided by Jason Slakter, MD.

          Results at 52 weeks

          Early FA
          Week 52
          Late FA
          Week 52
          Fundus Photograph
          Week 52
          Oct
          Week 52

          Summary

          Baseline characteristics


          ETDRS Letters
          60
          Snellen Equivalent
          20/60
          CRT (µm)
          284
          Total Lesion Size (mm2)
          12.26
          Active CNV (mm2)
          12.06
          Week 52
          ▲ from
          BL
          ETDRS Letters
          55
          -5
          Snellen Equivalent
          20/80
          CRT (µm)
          188
          -96
          Total Lesion Size (mm2)
          7.55
          -4.71
          Active CNV (mm2)
          0
          -12.26
          Study Eye Ocular Adverse Events
          Outcome
          conjunctival hemorrhage
          recovered
          subconjunctival hemorrhage
          recovered
          Non-ocular Adverse Events
          Outcome
          worsening of hypertension
          not specified
          reflux esophagitis
          not specified
          Additional Concomitant Medications
          During Study Period
          lisinopril dose increased, pantoprazole, clopidogrel, virion influenza vaccine, H1N1 vaccine

          “The week-52 photo shows resolution of the blood and lipid noted at baseline. The FA shows nearly total closure of the classic CNV but there is still some mild staining of the original central fibrovascular lesion. The OCT at week 52 shows reduction in edema and resolution of the subretinal fluid. The RPE thickening and outer retinal disruption may have contributed to the visual outcome in this patient.”

          All commentary is provided by Jason Slakter, MD.
          Baseline
          EARLY FA
          Baseline
          LATE FA
          Baseline
          Fundus Photograph
          Baseline
          OCT
          Baseline
          Week 4
          Week 12
          Week 52
          Early FA
          Baseline
          Week 52
          Late FA
          Baseline
          Week 52
          Fundus Photograph
          Baseline
          Week 52
          OCT
          Baseline
          Week 52

          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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          US-LEA-1934(1)

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