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Trial record 1 of 1 for:    oph1004
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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT01940887
First received: September 9, 2013
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Age-Related Macular Degeneration Drug: E10030 Drug: bevacizumab or aflibercept Drug: E10030 sham intravitreal injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

Resource links provided by NLM:


Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:
  • Mean change in visual acuity from baseline at the Month 12 visit. [ Time Frame: 12 months ]
    The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.


Enrollment: 645
Study Start Date: May 2014
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E10030 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: E10030
Other Name: Fovista®
Drug: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept
Other Names:
  • Avastin®
  • Eylea®
Active Comparator: Sham + bevacizumab or aflibercept
E10030 sham intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept
Other Names:
  • Avastin®
  • Eylea®
Drug: E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Other Name: Sham

Detailed Description:

Subjects will be randomized in a 1:1 ratio to the following dose groups:

  • 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.

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).

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940887

  Show 207 Study Locations
Sponsors and Collaborators
Ophthotech Corporation
  More Information

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT01940887     History of Changes
Other Study ID Numbers: OPH1004
Study First Received: September 9, 2013
Last Updated: February 7, 2017

Keywords provided by Ophthotech Corporation:
Wet AMD
choroidal neovascularization
Fovista®
E10030
Avastin®
Eylea®

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017