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NCT01585441 · ClinicalTrials.gov registry record · Phase 2
Finasteride for Chronic Central Serous Chorioretinopathy
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01585441 is a Phase 2 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 6 participants.
The verdict
NCT01585441, a Phase 2 study, was terminated before completion, sponsored by National Eye Institute (NEI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: * Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under the retina. It affects the macula, which is in the center of the retina and is needed for sharp, clear vision. In many cases, CSC resolves on its own and does not need treatment. However, in some cases it does not go away or comes back after treatment. This is known as chronic CSC. * Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can alter the effects certain of androgens. Researchers want to compare finasteride with a placebo to see if it is a safe and effective treatment for chronic CSC. Objectives: \- To see if finasteride is a safe and effective treatment for chronic CSC. Eligibility: \- Individuals at least 18 years of age who have chronic CSC in one or both eyes. Design: * Participants will be screened with a physical exam and medical history. A full eye exam will be performed. Blood and urine samples will also be collected. * Some participants may have photodynamic therapy (PDT), the standard treatment for CSC. PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3 months after PDT before starting the finasteride study. * Participants will be separated into two groups. One group will take finasteride 5 mg (formulated into capsules); the other group will take a placebo capsule. All participants will take the capsules for 3 months. * After 3 months on the assigned capsule (finasteride or placebo), all participants will have the opportunity to take finasteride for at least another 4 years and 9 months. This phase of the study is optional. * Participants will have regular study visits. At each visit, they will have physical exams and eye exams. They will also provide blood and urine samples. * During the first 3 months, participants will have 2 study visits. After 3 months, if the participant continues in the optional (or as needed) phase of the protocol, visits will occur at Month 6, Mon
Interventions
- DRUG Placebo
- DRUG Finasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01585441
The ClinicalTrials.gov registry entry for NCT01585441 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 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 2 interventions - of which Placebo is the first listed.
NCT01585441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01585441 about?
NCT01585441 is a clinical study titled "Finasteride for Chronic Central Serous Chorioretinopathy". Background: * Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under the retina. It affects the macula, which is in the center of the retina and is needed for sharp, clear vision. In many cases, CSC resolves on its own and does not need treatment. However, in some ca...
What is the current status of trial NCT01585441?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01585441?
The interventions under investigation include: Placebo (DRUG), Finasteride (DRUG).
Who is sponsoring clinical trial NCT01585441?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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