Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001615
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
1999-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-EI-0151 | None | None | None |