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An 18 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)

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ClinicalTrials.gov Identifier: NCT02387957
Recruitment Status : Terminated
First Posted : March 13, 2015
Last Update Posted : April 5, 2017
Sponsor:
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, and 16), for a total of 18 months.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 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. To evaluate the safety of Fovista (anti-PDGF BB) when administered in combination with anti-VEGF therapy as assessed by the incidence of test article related adverse events [ Time Frame: 18 Months ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02387957


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Sponsors and Collaborators
Ophthotech Corporation

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT02387957     History of Changes
Other Study ID Numbers: OPH1006
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

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

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