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Sponsors and Collaborators: |
University of Utah Genentech |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00474695 |
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Condition | Intervention | Phase |
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Age-Related Maculopathy |
Drug: Lucentis |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis |
Enrollment: | 65 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Active approved treatment
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Drug: Lucentis
0.05 mg intravitreal injection
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Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
California Retina Consultants | |
Santa Barbara, California, United States, 93103 | |
United States, Colorado | |
Porter Adventist Hospital | |
Denver, Colorado, United States, 80210 | |
United States, Utah | |
University of Utah, Moran Eye Center | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | Paul Bernstein, MD, PhD | University of Utah |
Responsible Party: | University of Utah ( Dr. Paul Bernstein ) |
Study ID Numbers: | 21441, SEAGUL |
Study First Received: | May 15, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00474695 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Exudative age-related macular degeneration |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |