Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration
Status:
Completed
Trial end date:
2000-05-01
Target enrollment:
Participant gender:
Summary
Age-related macular degeneration (AMD) represents the most common cause of blindness in
patients over the age of 60. The major cause of vision loss in this disease is due to the
development of choroidal neovascular membrane formation (CNVM). Several clinical trials have
proven that eyes with "well-defined" CNVM or lesions that can be readily demarcated with
fluorescein angiography can be successfully treated with laser photocoagulation. However, up
to 87% of eyes present with "ill-defined" CNVM or lesions that cannot be well demarcated on
fluorescein angiography and are not amenable to laser photocoagulation. No beneficial
treatment for this form of choroidal neovascularization has been established.
Histopathologic study has demonstrated the presence of inflammatory and reparative responses
in the retina of patients with ill-defined choroidal neovascularization. Since
corticosteroids have been shown to downregulate many of the cellular factors involved in both
inflammation and repair, the present study is designed to assess the ability of
corticosteroid injection around the eye to prevent severe vision loss associated with
"ill-defined" choroidal neovascularization in the setting of age-related macular
degeneration. The study will be organized as a randomized open label control clinical trial
involving 2 phases. Phase 1 involving 40 patients will establish the feasibility and safety
of this treatment modality. Phase 2 will place emphasis on efficacy of the study.