Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD subfoveal choroidal neovascularization Fovista® Avastin® Lucentis® Eylea®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

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).

Arms:
arm 1: Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection arm 2: Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection arm 3: Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection

Interventions: intervention 1: Fovista® intervention 2: bevacizumab intervention 3: ranibizumab intervention 4: aflibercept
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: