Status:
COMPLETED
Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Retinal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 c...
Detailed Description
Objective: Central serous chorioretinopathy (CSC) is a choroidal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its ow...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01227993
Start Date
October 1 2010
End Date
June 1 2013
Last Update
January 30 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892