NCT02591914

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Retinal Consultants of Arizona · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Fovista™	Anti-PDGF-B pegylated aptamer
DRUG	Lucentis®	Anti-VEGF
DRUG	Avastin®	Anti-VEGF
DRUG	Eylea®	Anti-VEGF

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-05-18
• Completion: 2016-05-24
• First posted: 2015-10-30
• Last updated: 2018-09-24

Locations

1 site across 1 country: United States