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

Ophthotech

Status and phase: Terminated; Phase 3

Conditions: Age-Related Macular Degeneration

Treatments: Drug: bevacizumab or aflibercept; Drug: E10030; Drug: E10030 sham injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940887

OPH1004

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 either Avastin® or Eylea® compared to Avastin® or Eylea® 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 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

Enrollment: 645 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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645 participants in 2 patient groups

E10030 + bevacizumab or aflibercept

Experimental group

Description:

E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Treatment:

Drug: E10030

Drug: bevacizumab or aflibercept

Sham + bevacizumab or aflibercept

Active Comparator group

Description:

E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Treatment:

Drug: E10030 sham injection

Drug: bevacizumab or aflibercept