Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Condition(s) targeted: Retinal Disease

Intervention: Finasteride (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: National Eye Institute (NEI)

Overall contact:
Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

Background:

- Central serous chorioretinopathy (CSCR) is a disease of the retina that is caused by an

accumulation of fluid under the retina. It affects the macula, the central part of the retina needed for sharp, clear vision and activities such as reading, sewing, and driving. In many cases, CSCR resolves on its own and does not require treatment. In some patients, however, the disease does not resolve or recurs, which is called chronic CSCR.

- Chronic CSCR may be caused in part by hormones called androgens. Finasteride is a drug

that can block the effects of androgens.

Objectives:

- To evaluate whether finasteride is safe to give to people with chronic CSCR.

- To evaluate whether finasteride can help preserve vision in patients with chronic CSCR.

- To determine whether future trials with finasteride are needed in patients with chronic

CSCR.

Eligibility:

- Patients 18 years of age and older with chronic CSCR who have visual acuity between

20/25 and 20/400 in the CSCR eye.

- Participants cannot be and should not become pregnant over the 6-month course of the

study (as finasteride is known to be harmful to unborn children).

Design:

- During the study, which consists of one baseline and six monthly visits, patients will

receive eye examinations that are part of CSCR routine care and examination. Eye examinations include the following:

- Dilation of the eye and photography (color and autofluorescence) of the inside of the

eye

- Optical coherence tomography, a procedure to measure retinal thickness

- Fluorescein angiography, a procedure in which dye is photographed as it travels through

the blood vessels in the eye

- Finasteride will be given to patients, one pill daily, for the first 3 months of the

study. Patients will not take finasteride in the second 3-month period, during which eye examinations will continue. If improvements observed during the first 3 months of the study diminish after finasteride is stopped, patients may be able to continue taking the medication.

- Blood and urine samples will be collected at the first, 3-month, and 6-month visits to

test for various hormone levels.

- Urine or serum pregnancy tests will be conducted at each study visit for women of

child-bearing age.

Official title: Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary outcome is the change in BCVA at 3 months compared with baseline.

Secondary outcome: Include the change in BCVA at 6 months compared to baseline and 3 months, change in maximum lesion height and lesion volume, change in fluid leakage, change in autofluorescence patterns and change in lab values.

Detailed description: Objective: Central serous chorioretinopathy (CSCR) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSCR tends to spontaneously resolve on its own with minimal sequelae, chronic CSCR tends to persist and lead to irreversible visual loss. The pathogenesis of CSCR is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study is to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSCR.

Study Population: Five participants with chronic CSCR, with the potential to replace up to two participants if some fail to reach the final study endpoint at six months.

Design: In this uncontrolled, unmasked, Phase I/II study, an oral dose of finasteride, 5 mg daily, will be administered to all participants for three months. Following this, the study medication will be withheld and participants will be observed for another three months. The total time of study enrollment for each participant will be six months.

Outcome Measures: The primary outcome will be the change in best-corrected visual acuity (BCVA) at three months compared to baseline. Safety outcomes include the number and severity of adverse effects of finasteride. Secondary efficacy outcomes include changes in BCVA at six months compared to the baseline and three months, changes in the maximum lesion height and lesion volume as measured on spectral domain optical coherence tomography (OCT), changes in leakage as seen on fluorescein angiography (FA), changes in autofluorescence patterns seen on fundus autofluorescence (FAF) imaging, changes in serum levels of testosterone and dihydrotestosterone (DHT), as well as changes in urine levels of cortisol.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- STUDY EYE - INCLUSION CRITERIA:

Eligible participants must have chronic CSCR in at least one eye as defined by all of the following criteria:

1. presence of subretinal fluid, as determined by spectral domain OCT, and

2. subretinal fluid must have been present for at least 3 months, or there is a recurrence of subretinal fluid with in the past 3 months, and

3. presence of characteristic fluorescein angiographic or autofluorescence features of CSCR, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy.

Participants must have a steady fixation in the study in the foveal or parafoveal area and media clear enough for good quality photographs

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

INCLUSION CRITERIA:

- Participant must be 18 years of age or older.

- Participant must understand and sign the protocol's informed consent document.

- Female participants of childbearing potential must not be pregnant or breast-feeding,

must have a negative pregnancy test at screening and must be willing to undergo monthly pregnancy tests throughout the study.

- Female participants of childbearing potential must agree to practice two acceptable

methods of birth control throughout the course of the study and for three months after their last oral dose of finasteride. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).

- Participants with hysterectomy or vasectomy are exempt from using two methods of

birth control. However, female participants with a tubal ligation are not exempt, and are required to practice another acceptable method of birth control.

- Participant agrees to take the appropriate precautions to ensure that persons who are

pregnant, nursing or of childbearing potential do not handle the finasteride tablets.

EXCLUSION CRITERIA:

- Participant is in another investigational study and actively receiving study therapy.

- Participant is unable to comply with study procedures or follow-up visits.

- Participant has evidence of ocular disease other than CSCR in either eye that may

confound the outcome of the study (e. g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.).

- Participant has evidence of CNV.

- Participant has abnormal liver function testing as defined by elevated alanine

aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are above greater than twice the respective upper limits of normal (ULN), i. e. ALT greater than 82 U/L and/or AST greater than 68 U/L. If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled if cleared by hepatology

- Participant is expected to need ocular surgery during the course of the trial.

- Participant is on steroid medication (oral, topical, or inhaled).

- Participant is on ocular or systemic medications known to be toxic to the lens,

retina or optic nerve.

- Participant has a systemic condition that, in the opinion of the investigator, would

preclude participation in the study (e. g., unstable medical status including blood pressure and glycemic control).

Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting

NIH Clinical Center Detailed Web Page

Related publications:

Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.

Tewari HK, Gadia R, Kumar D, Venkatesh P, Garg SP. Sympathetic-parasympathetic activity and reactivity in central serous chorioretinopathy: a case-control study. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3474-8.

Spahn C, Wiek J, Burger T, Hansen L. Psychosomatic aspects in patients with central serous chorioretinopathy. Br J Ophthalmol. 2003 Jun;87(6):704-8.

Starting date: February 2009
Ending date: January 2010
Last updated: August 24, 2009