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

Ophthotech

Status and phase: Terminated; Phase 3

Conditions: Age-Related Macular Degeneration

Treatments: Drug: E10030 sham intravitreal injection; Drug: ranibizumab; Drug: E10030

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944839

OPH1002

Details and patient eligibility

About

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).

Full 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).

Enrollment: 619 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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619 participants in 2 patient groups

E10030 + ranibizumab

Experimental group

Description:

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Treatment:

Drug: E10030

Drug: ranibizumab

Sham + ranibizumab

Active Comparator group

Description:

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Treatment:

Drug: E10030 sham intravitreal injection

Drug: ranibizumab