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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background:

* Central serous chorioretinopathy (CSC) is a disease in which fluid accumulates under the retina and can cause distorted vision. CSC often resolves on its own without treatment, but in chronic CSC the fluid persists and can lead to permanent visual loss. Chronic CSC may be partly caused by hormones called androgens.
* Finasteride is a drug that can modulate the effects of androgens; currently it is marketed as a treatment for male pattern baldness and benign prostate enlargement. The results of a previous brief study suggest that finasteride is safe and may help reduce the effects of chronic CSC. However, more long-term data are needed to evaluate whether finasteride is a safe and effective treatment for chronic CSC.

Objectives:

\- To collect more data on the safety and effectiveness of finasteride as a treatment for chronic central serous chorioretinopathy.

Eligibility:

\- Individuals who previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement on finasteride treatment.

Design:

* The study requires 11 visits to the NEI outpatient clinic over 5 years, with visits occurring every 6 months. Participants will be screened with a medical history, physical examination, eye examination, and blood and urine tests.
* At each visit, participants will receive a supply of finasteride pills to take every day and will need to bring any leftover finasteride pills to the following visit.
* Participants will have eye examinations to test vision, eye pressure, eye movements, and retinal thickness. Additional eye examinations will evaluate the retina's sensitivity to light and study the blood vessels and flow of blood in the eyes.
* Blood and urine samples will be taken throughout the study.
* After the end of the study, participants may be able to speak to their doctor about continuing finasteride treatments with a prescription.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00837252

Retinal Disease

COMPLETED PHASE1/PHASE2

Finasteride for Chronic Central Serous Chorioretinopathy

NCT01585441

Retinal Disease

TERMINATED PHASE2

A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss

NCT05910450

Alopecia, Androgenetic

ACTIVE_NOT_RECRUITING PHASE3

Finasteride Treatment of Severe Nodulocystic Acne

NCT02502669

NODULOCYSTIC ACNE

COMPLETED PHASE2

5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

NCT02876757

BPH Depression Suicide

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: Central serous chorioretinopathy (CSC) is a choroidal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve 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 may be involved. A recent study NCT00837252 (NIH protocol 09-EI-0075), "Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy," suggested that finasteride, an androgen modulating medication that is widely used in the treatment of various other conditions, may be efficacious as a treatment for chronic CSC. The objective of this study is to continue evaluation of participants in the completed NCT00837252 (NIH protocol 09-EI-0075) who clinically responded to treatment with finasteride.

Study Population: Up to five participants previously enrolled in NCT00837252 (NIH protocol 09-EI-0075) who demonstrated clinical improvement on finasteride treatment.

Design: This is a 5-year pilot extension study to allow participants who demonstrated clinical improvement with finasteride for chronic CSC to continue receiving finasteride as an off-label treatment. Study visits will occur every six months over the 5-year duration. Participants will receive finasteride when they have serous fluid present, unless deemed chronic non-responders (defined as serous fluid unchanged as compared to baseline or serous fluid stabilized with no further improvement while on finasteride treatment).

Outcome Measures: The primary outcome will be the change in best-corrected visual acuity (BCVA) at two years compared to baseline. Secondary outcome measures include the annual changes in BCVA, changes in subretinal fluid volume as measured on optical coherence tomography (OCT) (a 30% reduction in subretinal fluid from baseline is considered a "treatment success" by NEI standards), changes in leakage as observed on fluorescein angiography (FA), changes in plaque size as observed on indocyanine green angiography (ICG), changes in fundus autofluorescence patterns as observed on fundus autofluorescence (FAF) imaging, changes in microperimetry patterns, changes in serum levels of testosterone and dihydrotestosterone (DHT), as well as changes in urine levels of cortisol.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Finasteride

Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.

Group Type EXPERIMENTAL

Finasteride

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Finasteride

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Proscar Proprecia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participant previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement, as indicated by a reduction in subretinal fluid as measured on OCT.

Participant has subretinal fluid present in the macula that has a volume of at least 0.1 microliter causing visual change (such as reduced acuity, metamorphopsia or microperimetry deficits) and warrants treatment.

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

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. \[All of the NCT00837252 (NIH protocol 09-EI-0075) participants were male given the male predilection of this disease.\]

Exclusion Criteria

Participant has abnormal liver function testing (LFT) as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are 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 only if cleared by hepatology.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No