Finasteride for Chronic Central Serous Chorioretinopathy

Objective:

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.

Study Population:

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.

Design:

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.

Outcome Measures:

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.

- INCLUSION CRITERIA:

- Participant must have chronic 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 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 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.