Finasteride for Chronic Central Serous Chorioretinopathy
Status:
Terminated
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Background:
- Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under
the retina. It affects the macula, which is in the center of the retina and is needed
for sharp, clear vision. In many cases, CSC resolves on its own and does not need
treatment. However, in some cases it does not go away or comes back after treatment.
This is known as chronic CSC.
- Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can
alter the effects certain of androgens. Researchers want to compare finasteride with a
placebo to see if it is a safe and effective treatment for chronic CSC.
Objectives:
- To see if finasteride is a safe and effective treatment for chronic CSC.
Eligibility:
- Individuals at least 18 years of age who have chronic CSC in one or both eyes.
Design:
- Participants will be screened with a physical exam and medical history. A full eye exam
will be performed. Blood and urine samples will also be collected.
- Some participants may have photodynamic therapy (PDT), the standard treatment for CSC.
PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3
months after PDT before starting the finasteride study.
- Participants will be separated into two groups. One group will take finasteride 5 mg
(formulated into capsules); the other group will take a placebo capsule. All
participants will take the capsules for 3 months.
- After 3 months on the assigned capsule (finasteride or placebo), all participants will
have the opportunity to take finasteride for at least another 4 years and 9 months. This
phase of the study is optional.
- Participants will have regular study visits. At each visit, they will have physical
exams and eye exams. They will also provide blood and urine samples.
- During the first 3 months, participants will have 2 study visits. After 3 months, if the
participant continues in the optional (or as needed) phase of the protocol, visits will
occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits
may be needed.