Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Study Overview
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Brief Summary
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The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Detailed Description
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The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a Simultaneous Regimen (Fovista® administered with anti-VEGF same day) or Pre-Treatment Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Official Title
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A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Fovista® (anti-PDGF BB) plus anti-VEGF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either gender aged ≥ 50 years All fluorescein angiographic subtypes with presence of active choroidal neovascularization Exclusion Criteria: Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication Subjects with subfoveal scar or subfoveal atrophy Any ocular or periocular infection in the past twelve (12) weeks History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fovista® plus anti-VEGF Simultaneous<br>Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration. | Drug: Fovista® (anti-PDGF BB) plus anti-VEGF<br> <br> * Other names: anti-VEGF;|
| Experimental: Fovista® plus anti-VEGF Pre-Treatment<br>Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration. | Drug: Fovista® (anti-PDGF BB) plus anti-VEGF<br> <br> * Other names: anti-VEGF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects) | 2 years | 
| Number of Subjects With Serious Adverse Events | Number of subjects with serious adverse events in each arm | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®