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Trial record 1 of 1 for:    OPH1005
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Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT02214628
First received: August 5, 2014
Last updated: January 19, 2017
Last verified: January 2017
  Purpose
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy

Condition Intervention Phase
Age-related Macular Degeneration
Drug: Fovista® (anti-PDGF BB) plus anti-VEGF
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:
  • safety [ Time Frame: 2 years ]
    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


Enrollment: 101
Study Start Date: July 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fovista® (anti-PDGF BB) plus anti-VEGF
Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" or as a "Simultaneous" regimen followed by quarterly administration.
Drug: Fovista® (anti-PDGF BB) plus anti-VEGF

  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
  • All flourescein angiographic subtypes with presence of active choroidal neovascularization

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
  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: NCT02214628

Locations
United States, Arizona
Pheonix, Arizona, United States, 85014
United States, California
Beverly Hills, California, United States, 90211
Sacramento, California, United States, 95819
Sacramento, California, United States, 95841
Santa Ana, California, United States, 92705
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Illinois
Oak Forest, Illinois, United States, 60452
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Jackson, Michigan, United States, 49202
United States, Minnesota
Minneapolis, Minnesota, United States, 55435
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Ladson, South Carolina, United States, 29456
United States, Texas
Abilene, Texas, United States, 79606
Sponsors and Collaborators
Ophthotech Corporation
  More Information

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT02214628     History of Changes
Other Study ID Numbers: OPH1005
Study First Received: August 5, 2014
Last Updated: January 19, 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
Platelet-derived growth factor BB
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Angiogenesis Inducing Agents

ClinicalTrials.gov processed this record on May 23, 2017