A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

NCT01940887 Phase 3 TERMINATED Results posted

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).

Details

Lead sponsor	Ophthotech Corporation
Phase	Phase 3
Status	TERMINATED
Enrolment	645
Start date	2014-05
Completion	2017-09

Conditions

• Age-Related Macular Degeneration

Interventions

• E10030
• bevacizumab or aflibercept
• E10030 sham injection

Primary outcomes

• Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) — 12 months
  The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.

Countries

United States, Argentina, Australia, Austria, Brazil, Canada, Colombia, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Norway, Poland, Portugal, Slovakia, Spain