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Sponsored by: |
GenVec |
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Information provided by: | GenVec |
ClinicalTrials.gov Identifier: | NCT00109499 |
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 |
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Macular Degeneration |
Drug: AdGVPEDF.11D |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Dose Comparison, Safety Study |
Official Title: | An Open-Label, Phase I, Single Administration, Dose- Escalation Study of AdGVPEDF.11D in Neovascular Age-Related Macular Degeneration (AMD) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA - Jules Stein Eye Research Center | |
Los Angeles, California, United States, 90095-7000 | |
Retinal Transplantation Laboratory | |
Los Angeles, California, United States, 90033-4682 | |
Retina-Vitreous Associates Medical Group | |
Beverly Hills, California, United States, 90211 | |
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 |
Study ID Numbers: | GV-003.001 |
Study First Received: | April 28, 2005 |
Last Updated: | March 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00109499 |
Health Authority: | United States: Food and Drug Administration |
Wet Age-Related Macular Degeneration Age-Related Maculopathies |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |