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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00837252 |
Purpose
Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC.
Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months.
Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinal Disease |
Drug: Finasteride |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy |
| Enrollment: | 5 |
| Study Start Date: | February 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Finasteride |
Drug: Finasteride
Participants received 5mg of oral finasteride daily for three months.
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Participant-Level Inclusion Criteria
Female participants of childbearing potential must agree to practice two* acceptable methods of birth control throughout the course of the study and for three months after their last oral dose of finasteride. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).
*Participants with hysterectomy or vasectomy are exempt from using two methods of birth control. However female participants with a tubal ligation are not exempt and are required to practice another acceptable method of birth control.
Participant-Level Exclusion Criteria
Study Eye Inclusion Criteria
Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria:
Contacts and Locations| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Catherine B Meyerle, MD | National Eye Institute (NEI) |
More Information
| Responsible Party: | Catherine Meyerle, MD/National Eye Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00837252 History of Changes |
| Other Study ID Numbers: | 090075, 09-EI-0075 |
| Study First Received: | February 4, 2009 |
| Results First Received: | April 21, 2011 |
| Last Updated: | May 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Central Serous Chorioretinopathy Finasteride Proscar Retinal Eye Disease |
|
Retinal Diseases Central Serous Chorioretinopathy Eye Diseases Finasteride |
5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |