Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
| Status: | Archived |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
| End Date: | October 2015 |
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 persists and can lead to permanent visual loss.
Chronic CSC may partly be caused by hormones called androgens, such as testosterone.
- Finasteride is a drug that can block 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 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.
Objective:
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. A recent NIH protocol (09-EI-0075), Pilot Study for the Evaluation
of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, suggested that
finasteride, an anti-androgen medication that is widely used in the treatment of various
other conditions, may be efficacious as a treatment for chronic CSC. The objective of this
study is to continue evaluation of participants in the completed NIH protocol 09-EI-0075 who
clinically responded to treatment with finasteride.
Study Population:
Up to five participants previously enrolled in NIH protocol 09-EI-0075 who demonstrated
clinical improvement on finasteride treatment.
Design:
This is a 5-year pilot extension study to allow participants who demonstrated clinical
improvement with finasteride for chronic CSC to continue receiving finasteride as an
off-label treatment. Study visits will occur every six months over the 5-year duration.
Participants will receive finasteride when they have serous fluid present, unless deemed
chronic non-responders (defined as serous fluid unchanged as compared to baseline or serous
fluid stabilized with no further improvement while on finasteride treatment).
Outcome Measures:
The primary outcome will be the change in best-corrected visual acuity (BCVA) at two years
compared to baseline. Secondary outcome measures include the annual changes in BCVA, changes
in subretinal fluid volume as measured on optical coherence tomography (OCT) (a 30%
reduction in subretinal fluid from baseline is considered a treatment success by NEI
standards), changes in leakage as observed on fluorescein angiography (FA), changes in
plaque size as observed on indocyanine green angiography (ICG), changes in fundus
autofluorescence patterns as observed on fundus autofluorescence (FAF) imaging, changes in
microperimetry patterns, changes in serum levels of testosterone and dihydrotestosterone
(DHT), as well as changes in urine levels of cortisol.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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