Finasteride for Chronic Central Serous Chorioretinopathy

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Eye Institute (NEI)
• Collaborators: The Emmes Company, LLC; The EMMES Corporation
• Treatments: Finasteride

Criteria

INCLUSION CRITERIA:

• Participant must have chronic Central Serous Chorioretinopathy (CSC) in at least one eye as defined by all of the following criteria. This eye will be referred to as the study eye.

• The presence of subretinal fluid, as determined by optical coherence tomography (OCT), AND

• The subretinal fluid must have been present for at least three months or recurrent in cases of chronic CSC/diffuse retinal pigment epitheliopathy, AND/OR

• The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy noted on fluorescein or descending tract lesions on autofluorescence.

• Participant must have a steady fixation in the study eye.

• Participant must have media clear enough in the foveal or parafoveal area in the study eye for good quality photographs.

• Participant must have visual acuity between 20/25 and 20/400 in the study eye.

EXCLUSION CRITERIA:

• Participant has evidence of choroidal neovascularization (CNV) in the study eye.

• Participant is expected to need ocular surgery in the study eye during the first three months of the study.

• Participant has had photodynamic therapy (PDT) or focal laser treatment in the study eye within three months prior to enrollment or is expected to need PDT or focal laser treatment in the study eye during the first three months of the study.