Finasteride for Chronic Central Serous Chorioretinopathy
- 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.
- To see if finasteride is a safe and effective treatment for chronic CSC.
- Individuals at least 18 years of age who have chronic CSC in one or both eyes.
- 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; the other group will take a placebo pill. They will take these pills for 3 months.
- After 3 months on the assigned pill (finasteride or placebo), all participants will have the opportunity to take finasteride for at least another 4 years and 9 months.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase II, Randomized, Placebo-Controlled Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy|
- Proportion of participants with an improvement in BCVA of more than or equal to 15 letters and proportion with a reduction in subretinal fluid volume of more than or equal to 50 percent at 3 months compared to baseline.
- Changes in BCVA, fluid volume, central retinal thickness, leakage, existing plaque(s), autofluorescence patterns, mean macular sensitivity, serum levels of testosterone and dihydrotestosterone, urine levels of cortisol during the study period.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Central serous chorioretinopathy (CSC) is a chorioretinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to resolve spontaneously 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. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. A previous study performed at the NEI demonstrated a reduction in the amount of subretinal fluid among participants treated with 5 mg of finasteride. The objective of this study is to further investigate the efficacy of oral finasteride as a treatment for chronic CSC.
Thirty-eight participants with chronic CSC will be enrolled initially. However, up to an additional four participants may be enrolled to account for participants who withdraw from the study prior to reaching Month 3.
In this Phase II, single-center, placebo-controlled, double-masked, randomized trial, investigational product will be administered to two different groups. Half of the participants will be randomized to 5 mg oral finasteride for the initial three months. The other half of the participants will be randomized to placebo for the first three months. At the end of three months of treatment, all participants may be followed for at least four years and nine months. During this follow-up period, all participants will be able to receive finasteride therapy PRN if subretinal fluid re-emerges. The PRN phase will last until the last participant completes the five years of follow-up. Other standard care treatments, such as photodynamic therapy, will also be permitted after the primary outcome at three months.
The primary outcome for regulatory filing is the proportion of participants with an improvement in best-corrected visual acuity (BCVA) of greater than or equal to 15 letters at three months compared to baseline in the study eye. The primary outcome for publication of the study results is the proportion of participants with a subretinal fluid volume decrease of greater than or equal to 50% at three months compared to baseline in the study eye. Secondary efficacy outcomes include changes in BCVA, changes in the maximum retinal volume as measured on optical coherence tomography (OCT), changes in central retinal thickness on OCT, changes in leakage as seen on fluorescein angiography (FA), changes in size of existing plaque(s) on indocyanine green (ICG) angiography, changes in autofluorescence patterns seen on fundus autofluorescence (FAF) imaging, changes in mean macular sensitivity as assessed by microperimetry, changes in serum levels of testosterone and dihydrotestosterone (DHT), as well as changes in urine levels of cortisol during the study period. Safety outcomes include the number and severity of adverse reactions from the investigational product and the number of withdrawals.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Emily Y Chew, M.D.||National Eye Institute (NEI)|