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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: Clinical Trial Phase 2 study, sponsored by National Eye Institute (NEI).
NCT01585441 is a Phase 2 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Interventions
- DRUG Placebo
- DRUG Finasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
Why NCT01585441 stopped before completion
NCT01585441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01585441 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01585441's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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