Clinical Trial Testing the Safety and Efficacy of Intravitreal Sustained ? Released Fluocinolone Acetonide in Choroidal Neovascularization Associated with Age-related Macular DegenerationBased on the findings from an animal model of choroidal neovascularization in which macrophages have been identified and the notion that choroidal neovascularization in age-related macular degeneration patients may represent an aberrant wound healing response, a clinical trial has been initiated testing the safety and potential efficacy of intravitreal sustained release fluocinolone acetonide in patients with neovascular age-related macular degeneration. The study has been deigned as a prospective, randomized 2 dose masked study. Entrance criteria include patients with demonstrated AMD and CNVM with both classic and predominate (>50%) occult features. The primary outcome measures are the determination of safety issues related to the implant and a change in the visual acuity while secondary outcome measures include alterations in fluorescein angiographic findings and changes in visual function as measured by the NEI/VFQ. A total of 16 patients are scheduled to be enrolled.Publications:Baffi J, Byrnes G, Chan CC, Csaky KG. Choroidal neovascularization in the rat induced by adenovirus mediated expression of vascular endothelial growth factor. Invest Ophthalmol Vis Sci 2000; 41:3582-3589.Csaky KG, Reed G, Robinson M. A Randomized, Prospective Study of Sustained-Release Fluocinolone Acetonide Implant for Choroidal Neovascularization with Age-Related Macular Degeneration. Clinical Trial 2000

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Intramural Research (Z01)
Project #
1Z01EY000353-01
Application #
6420728
Study Section
(LI)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2000
Total Cost
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
United States
Zip Code