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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: Completed Phase 1 study, sponsored by National Eye Institute (NEI).

NCT01227993 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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 Finasteride

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2010-10
Est. Completion 2013-06
Phase Phase 1
National Eye Institute (NEI)

221 total trials

What the finished NCT01227993 record still lists

NCT01227993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Finasteride is the first listed.

NCT01227993 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01227993's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01227993, the US trial registry maintained by the National Library of Medicine. NCT01227993 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.