Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration

Macular Degeneration Clinical Trial

Official title: Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

• NCT number: NCT00001615
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 1
• Start date: July 1997
• Completion date: May 2000