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

Phase 3

Terminated

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: E10030; Drug: ranibizumab; Drug: E10030 sham intravitreal injection

• Registration Number: NCT01944839
• 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 Lucentis® compared to Lucentis® 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 dose groups:

* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye

* Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-07-11
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-08
• Results First Posted: 2018-08-10
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 619

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
Sham + ranibizumab	E10030 sham intravitreal injection	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
E10030 + ranibizumab	E10030	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Sham + ranibizumab	ranibizumab	E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
E10030 + ranibizumab	ranibizumab	E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Primary Outcome Measures

Name	Time	Method
Mean Change in Visual Acuity From Baseline to 12 Months	12 Months	The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.