An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Ma

• Status: Completed
• Trial end date: 2016-05-24

Summary

The objectives of this study are to establish the safety and tolerability of intravitreous administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration.

Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are present PER INVESTIGATOR DISCRETION:

• ≥ 5 ETDRS letters loss OR;

• Significant hemorrhage OR;

• New or increased RPE elevation consistent with increased disease activity OR;

• Increased neovascular lesion size OR;

• New or increased foveal intraretinal fluid

If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above, Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as monotherapy).

Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24 administrations.

• Phase: Phase 1

Details

• Lead Sponsor: Retinal Consultants of Arizona
• Collaborator: Ophthotech Corporation
• Treatments: Bevacizumab; Ranibizumab