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

NCT01227993 | Completed Phase 1 Results

• 2 other identifiers: 11001211-EI-0012
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinal Disease

Keywords

Central Serous Chorioretinopathy; Finasteride; Proscar; Retinal Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline

  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.

  Baseline and 2 years

Secondary Outcomes (14)

• Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline

  Baseline and 2 years

• Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline

  Baseline and 1 year

• Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline

  Baseline and 1 year

• Change in Serum Testosterone Levels at Two Years Compared to Baseline

  Baseline and 2 years

• Change in Serum DHT Levels at Two Years Compared to Baseline

  Baseline and 2 years

Study Arms (1)

Finasteride

EXPERIMENTAL

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.

Drug: Finasteride

Interventions

Finasteride DRUG

Also known as: Proscar, Proprecia

Finasteride

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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

Related Links

• NIH Clinical Center Detailed Web Page

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

Results Point of Contact

• Title: Catherine Meyerle, MD
• Organization: National Eye Institute

meyerlec@nei.nih.gov

301-435-7821

Study Officials

• Catherine Meyerle, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 30, 2024
• Results First Posted: September 23, 2013

Record last verified: 2013-10

Locations

US (1)