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

Conditions

• Age-Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• E10030 — DRUG
• bevacizumab or aflibercept — DRUG
  Patients are randomized to receive either bevacizumab or aflibercept
• E10030 sham injection — DRUG
  Pressure on the eye with a syringe with no needle

Study Details

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).

Key Dates

Start date

May 31, 2014

Status verified

Sep 2020

Primary completion

Jun 30, 2017

Completion

Sep 30, 2017

Study Design

Enrollment

645 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: E10030 + bevacizumab or aflibercept
  E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
• Active Comparator: Sham + bevacizumab or aflibercept
  E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Primary Outcome Measure

Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) [ Time Frame: 12 months ]

Locations (100)

Find similar trials in Gilbert, AZ

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