CompletedPhase 1/2

Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

United States3 participantsStarted 2010-10

Plain-language 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 with a prescription.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: Participant 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, as indicated by a reduction in subretinal fluid as measured on OCT. Participant has subretinal fluid present in the macula that has a volume of at least 0.1 microliter causing visual change (such as reduced acuity, metamorphopsia or microperimetry deficits) and warrants treatment. Participant must understand and sign the protocol's informed consent document. Participant agrees to take the appropriate precautions to ensure that persons who are pregnant, nursing or of childbearing potential do not handle the finasteride tablets. \[All of the NCT00837252 (NIH protocol 09-EI-0075) participants were male given the male predilection of this disease.\] EXCLUSION CRITERIA: Participant has abnormal liver function testing (LFT) as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN) (i.e., ALT greater than 82 U/L and/or AST greater than 68 U/L). If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled only if cleared by hepatology. Participant is on steroid medication (oral, topical or inhaled).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline

Timeframe: Baseline and 2 years

Trial details

NCT IDNCT01227993

SponsorNational Eye Institute (NEI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2013-07-02

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