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 Macular Degeneration

Neovascular Age-Related Macular Degeneration Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

• NCT number: NCT02591914
• Study type: Interventional
• Source: Retinal Consultants of Arizona
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Completion date: May 24, 2016