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
Recruiting in Palo Alto (17 mi)
+174 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Ophthotech Corporation
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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).
Research Team
Eligibility Criteria
Inclusion Criteria
Subjects of either gender aged ≥ 50 years
Active subfoveal choroidal neovascularization (CNV) secondary to AMD
Presence of sub-retinal hyper-reflective material (SD-OCT)
Treatment Details
Interventions
- Bevacizumab or Aflibercept (Anti-angiogenic Agent)
- E10030 (Anti-angiogenic Agent)
- E10030 sham injection (Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: E10030 + bevacizumab or afliberceptExperimental Treatment2 Interventions
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Group II: Sham + bevacizumab or afliberceptActive Control2 Interventions
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ophthotech Corporation
Lead Sponsor
Trials
14
Recruited
2,800+