Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Information provided by:
GenVec
ClinicalTrials.gov Identifier:
NCT00109499
First received: April 28, 2005
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

The primary purpose of this study is to assess the safety of AdGVPEDF.11D when given to patients with "wet" age-related macular degeneration (AMD). AdGVPEDF.11D is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for the PEDF (pigment epithelium-derived factor) protein. PEDF is a protein that naturally exists in the human eye, but whose levels are altered in diseases characterized by ocular neovascularization like AMD. The PEDF protein is known to have anti-angiogenic effects or, in other words, it has the ability to inhibit growth of new blood vessels.

AdGVPEDF.11D will be delivered once via intravitreal injection into one eye. The injected eye will be the eye with the worst visual acuity.


Condition Intervention Phase
Macular Degeneration
Drug: AdGVPEDF.11D
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by GenVec:

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 50 years;
  • Severe neovascular AMD in at least one eye responsible for a best corrected vision of 20/200 or worse in the study eye (if both eyes have neovascular AMD and equal visual acuity scores, the study eye will be determined by the investigator);
  • Best corrected visual acuity in the fellow eye must be equal to or better than the study eye;
  • Fluorescein angiography of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion. The subfoveal component must consist of CNV (choroidal neovascularization), blood or fibrosis. The total size of the lesion must be ≤12 MPS disc areas. The presence of a leaking subfoveal choroidal neovascular lesion will be evaluated by the investigator at the clinical site to determine patients' eligibility.
  • Must not be candidates for (including patients who have had treatment with either modality in the past and are no longer candidates) or must have refused treatment with subfoveal laser photocoagulation or PDT (photodynamic therapy);
  • Informed consent;
  • Able to comply with protocol requirements including follow-up visits.

Exclusion Criteria:

  • Liver enzymes > 2 x ULN (ALT, AST, bilirubin);
  • Clinical evidence of active infection of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus;
  • Other treatment for AMD in the study eye within the last twelve weeks prior to Day 1;
  • Other experimental medications within the last four weeks prior to Day 1;
  • Significant retinal disease other than neovascular AMD, such as diabetic retinopathy or retinal vascular occlusion;
  • Significant non-retinal disease such as ocular atrophy;
  • Cataract or other significant media opacity that might compromise examination and photography of the posterior segment;
  • Other causes of choroidal neovascularization such as pathologic myopia ( > 8 diopters), ocular histoplasmosis or angioid streaks;
  • Evidence of inflammation (grade 1 or higher) in the anterior and/or posterior chambers;
  • Cataract surgery or submacular surgery within 3 months;
  • Prior ocular treatment with radiation;
  • Known allergy to fluorescein;
  • Abnormal prothrombin or partial thromboplastin time ( > 1.5 X ULN) or anticoagulant therapy that cannot be withheld for treatment.
  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: NCT00109499

Locations
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
UCLA - Jules Stein Eye Research Center
Los Angeles, California, United States, 90095-7000
Retinal Transplantation Laboratory
Los Angeles, California, United States, 90033-4682
United States, Florida
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States, 33426
United States, Maryland
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, United States, 21287
United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States, 48201-1423
United States, Oregon
Casey Eye Institute
Portland, Oregon, United States, 97201
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
GenVec
  More Information

No publications provided

Responsible Party: Paul Fischer, PhD, GenVec
ClinicalTrials.gov Identifier: NCT00109499     History of Changes
Other Study ID Numbers: GV-003.001
Study First Received: April 28, 2005
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GenVec:
Wet Age-Related Macular Degeneration
Age-Related Maculopathies

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014