A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Detailed Description
-----------------
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows: Avastin® 1.25 mg/eye (20 subjects) Lucentis® 0.5 mg/eye (20 subjects) Eylea® 2.0 mg/eye (20 subjects) Subjects will be stratified by lesion size (≤2 DA vs. >2 DA). Subjects will be treated with combination therapy of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months. When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Fovista®
* Drug: bevacizumab
* Drug: ranibizumab
* Drug: aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either gender aged ≥ 50 years. Active subfoveal choroidal neovascularization (CNV) due to AMD. 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
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fovista® plus bevacizumab<br>Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection | Drug: Fovista®<br> <br> Drug: bevacizumab<br> <br> * Other names: Avastin®;|
| Experimental: Fovista® plus ranibizumab<br>Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection | Drug: Fovista®<br> <br> Drug: ranibizumab<br> <br> * Other names: Lucentis®;|
| Experimental: Fovista® plus aflibercept<br>Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection | Drug: Fovista®<br> <br> Drug: aflibercept<br> <br> * Other names: Eylea®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Numer of Systemic Adverse Events | Number of Patients with Systemic Adverse Events | 2 years | 
| Total Number of Other Adverse Events (>5%) | Number of Patients with Other Adverse Events | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lucentis®, Eylea®, Wet AMD, subfoveal choroidal neovascularization, Fovista®, Avastin®