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)



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:3/7/2019
Start Date:April 26, 2016
End Date:January 2017

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

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).

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.
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