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

Phase 3

Terminated

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: E10030; Drug: bevacizumab or aflibercept; Drug: E10030 sham injection

• Registration Number: NCT01940887
• Lead Sponsor: Ophthotech Corporation

Brief 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).

Detailed Description

Subjects will be randomized in a 1:1 ratio to the following two arms per study design:

* Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye

* Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye

Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months.

Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Study Start: 2014-05
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Results First Submitted: 2019-06-18
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-29
• Results First Posted: 2020-09-30
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 645

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)

Exclusion Criteria

• Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
• Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
• Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
• Subjects with subfoveal scar or subfoveal atrophy are excluded
• Diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E10030 + bevacizumab or aflibercept	bevacizumab or aflibercept	E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Sham + bevacizumab or aflibercept	bevacizumab or aflibercept	E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Sham + bevacizumab or aflibercept	E10030 sham injection	E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
E10030 + bevacizumab or aflibercept	E10030	E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Primary Outcome Measures

Name	Time	Method
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.