Finasteride for Chronic Central Serous Chorioretinopathy

NCT01585441 | Terminated Phase 2 Results DMC

• 2 other identifiers: 12011912-EI-0119
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Disease

Keywords

Finasteride; Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.

  This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.

  Month 3

• Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline

  This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.

  Month 3

Secondary Outcomes (21)

• Number of Participants With Adverse Reactions Related to the Investigational Product

  Duration of the study, up to 1.5 years

• Number of Participants Who Withdrew From the Study

  Duration of the study, up to 1.5 years

• Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline

  Month 3

• Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline

  Final Study Visit

• Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline

  Month 3

Study Arms (2)

Finasteride 5 mg

EXPERIMENTAL

Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.

Drug: Finasteride

Placebo

PLACEBO COMPARATOR

Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.

Drug: Placebo

Interventions

Finasteride DRUG

Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.

Also known as: Propecia®, Proscar®

Finasteride 5 mg

Placebo DRUG

Capsule with no active ingredients to mimic finasteride

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead
• The Emmes Company, LLC: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

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

  PMID: 2469527 BACKGROUND

• 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. doi: 10.1167/iovs.05-1246.

  PMID: 16877418 BACKGROUND

• 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. doi: 10.1136/bjo.87.6.704.

  PMID: 12770965 BACKGROUND

• Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

  PMID: 40522203 DERIVED

MeSH Terms

Conditions

Retinal Diseases; Central Serous Chorioretinopathy

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Limitations and Caveats

This study was terminated early due to lack of enrollment.

Results Point of Contact

• Title: Emily Chew, MD
• Organization: National Eye Institute

emily.chew@nih.gov

301-496-6583

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2014
• Results First Posted: December 4, 2014

Record last verified: 2014-11

Locations

US (1)