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NCT00001615 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT00001615 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 180 participants.
The verdict
NCT00001615, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study 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.
Interventions
- DRUG Corticosteroid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 1997-07 |
| Est. Completion | 2000-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001615
The ClinicalTrials.gov registry entry for NCT00001615 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Corticosteroid is the first listed.
NCT00001615 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001615 about?
NCT00001615 is a clinical study titled "Phase I Study of Corticosteroid Treatment of Ill-Defined Choroidal Neovascularization in Age-Related Macular Degeneration". 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-d...
What is the current status of trial NCT00001615?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 1997-07. Estimated completion is 2000-05.
What interventions are being tested in trial NCT00001615?
The interventions under investigation include: Corticosteroid (DRUG).
Who is sponsoring clinical trial NCT00001615?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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