Phase 2 N=3 Treatment

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

Retinal Disease

Bottom Line

View on ClinicalTrials.gov: NCT01227993 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline — 0 ETDRS letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Finasteride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline	—	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline	-1.00	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline	—	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline	0.33	—
SECONDARY Change in Serum Testosterone Levels at Two Years Compared to Baseline	-28.67	—
SECONDARY Change in Serum DHT Levels at Two Years Compared to Baseline	10.67	—
SECONDARY Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline	2.75	—
SECONDARY Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline	—	—
SECONDARY Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline	—	—
SECONDARY Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline	—	—
SECONDARY Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline	—	—
SECONDARY Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline	—	—
SECONDARY Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline	—	—
SECONDARY Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline	—	—
SECONDARY Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline	—	—

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01227993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.