Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
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.