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NCT01227993 · ClinicalTrials.gov registry record · Phase 1
Extension 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
- 3
- Enrollment target
NCT01227993 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 3 participants.
The verdict
NCT01227993, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the retina and can cause distorted vision. CSC often resolves on its own without treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC may be partly caused by hormones called androgens. * Finasteride is a drug that can modulate the effects of androgens; currently it is marketed as a treatment for male pattern baldness and benign prostate enlargement. The results of a previous brief study suggest that finasteride is safe and may help reduce the effects of chronic CSC. However, more long-term data are needed to evaluate whether finasteride is a safe and effective treatment for chronic CSC. Objectives: \- To collect more data on the safety and effectiveness of finasteride as a treatment for chronic central serous chorioretinopathy. Eligibility: \- Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment. Design: * The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits occurring every 6 months. Participants will be screened with a medical history, physical examination, eye examination, and blood and urine tests. * At each visit, participants will receive a supply of finasteride pills to take every day and will need to bring any leftover finasteride pills to the following visit. * Participants will have eye examinations to test vision, eye pressure, eye movements, and retinal thickness. Additional eye examinations will evaluate the retina's sensitivity to light and study the blood vessels and flow of blood in the eyes. * Blood and urine samples will be taken throughout the study. * After the end of the study, participants may be able to speak to their doctor about continuing finasteride treatments wit
Interventions
- DRUG Finasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227993
The ClinicalTrials.gov registry entry for NCT01227993 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 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.
NCT01227993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01227993 about?
NCT01227993 is a clinical study titled "Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy". Background: * Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the retina and can cause distorted vision. CSC often resolves on its own without treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC may be partly cause...
What is the current status of trial NCT01227993?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2010-10. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01227993?
The interventions under investigation include: Finasteride (DRUG).
Who is sponsoring clinical trial NCT01227993?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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