A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

NCT01940887 ↗

Phase 3 Terminated 645 enrolled Ophthotech Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Timeline

Start: 2014-05
Primary completion: 2017-06
Completion: 2017-09

Publications

Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PEGPLERANIB SODIUM	Aptamer	1.5 mg	Intravitreal
Background	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Background	Bevacizumab	Monoclonal antibody	1.25 mg	Intravitreal

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

Summary

Timeline

Publications

Drugs

Indications