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

Last updated: October 19, 2024
Sponsor: Ophthotech Corporation
Overall Status: Terminated

Phase

3

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

E10030

bevacizumab or aflibercept

E10030 sham injection

Clinical Study ID

NCT01940887
OPH1004
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oralsupplements 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. Anyprior thermal laser in the macular region, regardless of indication

  • Subjects with subfoveal scar or subfoveal atrophy are excluded

  • Diabetes mellitus

Study Design

Total Participants: 645
Treatment Group(s): 3
Primary Treatment: E10030
Phase: 3
Study Start date:
May 01, 2014
Estimated Completion Date:
September 30, 2017

Study 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

Connect with a study center

  • Buenos Aires, C1112AAI
    Argentina

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  • Cordoba, 5000
    Argentina

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  • Santa Fe, 2000
    Argentina

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  • Albury, New South Wales 2640
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  • Parramatta, New South Wales 2150
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  • Sydney, New South Wales 2000
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    West Mead, New South Wales 2145
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  • Graz, 8036
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    São Paolo, 04023-062
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  • Winnipeg, Manitoba R3C 1A2
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  • Mississauga, Ontario L4W 1W9
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  • Brno, 625 00
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