Working... Menu
Trial record 1 of 1 for:    OPH1006
Previous Study | Return to List | Next Study

A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02387957
Recruitment Status : Terminated
First Posted : March 13, 2015
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
Ophthotech Corporation

Brief Summary:
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Fovista® Drug: bevacizumab Drug: ranibizumab Drug: aflibercept Phase 2

Detailed Description:

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

  • Avastin® 1.25 mg/eye (20 subjects)
  • Lucentis® 0.5 mg/eye (20 subjects)
  • Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 26, 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fovista® plus bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Drug: Fovista®
Drug: bevacizumab
Other Name: Avastin®

Experimental: Fovista® plus ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Drug: Fovista®
Drug: ranibizumab
Other Name: Lucentis®

Experimental: Fovista® plus aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Drug: Fovista®
Drug: aflibercept
Other Name: Eylea®

Primary Outcome Measures :
  1. Total Numer of Systemic Adverse Events [ Time Frame: 2 years ]
    Number of Patients with Systemic Adverse Events

  2. Total Number of Other Adverse Events (>5%) [ Time Frame: 2 years ]
    Number of Patients with Other Adverse Events

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years.
  • Active subfoveal choroidal neovascularization (CNV) due to AMD.

Exclusion Criteria:

  • 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
  • Any ocular or periocular infection in the past twelve (12) weeks.
  • History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02387957

  Show 24 Study Locations
Sponsors and Collaborators
Ophthotech Corporation

Layout table for additonal information
Responsible Party: Ophthotech Corporation Identifier: NCT02387957     History of Changes
Other Study ID Numbers: OPH1006
First Posted: March 13, 2015    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time

Keywords provided by Ophthotech Corporation:
subfoveal choroidal neovascularization

Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors