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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

NCT01940887 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2024-10-31

Study results available
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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).

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

E10030

DRUG

bevacizumab or aflibercept

Patients are randomized to receive either bevacizumab or aflibercept

DRUG

E10030 sham injection

Pressure on the eye with a syringe with no needle

Sponsors & Collaborators

  • Ophthotech Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940887 on ClinicalTrials.gov