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Finasteride for Chronic Central Serous Chorioretinopathy

NCT01585441 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-12-04

Study results available
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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

Interventions

DRUG

Finasteride

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.

DRUG

Placebo

Capsule with no active ingredients to mimic finasteride

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Emily Y Chew, M.D. · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585441 on ClinicalTrials.gov