Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)

Study Overview
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Brief Summary
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This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.

Official Title
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An Open-Label Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection) in Patients With Neovascular Age-Related Macular Degeneration

Conditions
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Age - Related Macular Degeneration (AMD)

Intervention / Treatment
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* Drug: Intravitreal Aflibercept Injection (IAI)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria include but are not limited to: Men or women great than or equal to 50 years of age with unilateral neovascular AMD BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye The CNV area must be at least 50% of total lesion size Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization Exclusion criteria include but are not limited to: Neovascular AMD in the fellow eye Corneal endothelial measures as judged by an independent reading center Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening Contact lens wear in either eye within 6 months of screening History of angle closure glaucoma in either eye Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye Any prior ocular trauma (blunt or penetrating) in either eye Embedded corneal foreign body in either eye Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye Ocular media of insufficient quality to obtain fundus and OCT images in the study eye Any prior ocular inflammation/infection in either eye within 3 months of the screening visit Any prior use of amantadine Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV) Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening Uncontrolled diabetes mellitus (DM) (HbA1c ≥8) Current treatment with systemic anti-VEGF therapeutics at screening Known serious allergy to the fluorescein sodium for injection in angiography Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device. Positive serum hCG pregnancy test at the screening visit

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label IAI<br> | Drug: Intravitreal Aflibercept Injection (IAI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. | Baseline to Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was Dry at Week 52 and at Week 100 (LOCF) | Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data. | Baseline to Week 100 | 
| Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed. | At week 52 and At week 100 | 
| Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. | Baseline to Week 52 | 
| Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | Baseline to Week 100 | 
| Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF) | Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. | Baseline to Week 100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD