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NCT00837252 · ClinicalTrials.gov registry record · Phase 1
Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00837252 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00837252, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC. Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months. Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.
Interventions
- DRUG Finasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00837252
The ClinicalTrials.gov registry entry for NCT00837252 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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 Finasteride is the first listed.
NCT00837252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00837252 about?
NCT00837252 is a clinical study titled "Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy". Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of C...
What is the current status of trial NCT00837252?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2009-02. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00837252?
The interventions under investigation include: Finasteride (DRUG).
Who is sponsoring clinical trial NCT00837252?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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