Clinical trial NCT01227993: Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Official title: Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retinal Disease
Keywords: Central Serous Chorioretinopathy
Finasteride
Proscar
Retinal Eye Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2010-10-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline
timeFrame: Baseline and 1 year
measure: Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline
timeFrame: Baseline and 1 year
measure: Change in Serum Testosterone Levels at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Serum DHT Levels at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
measure: Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Catherine Meyerle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.
citation: 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.
citation: 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.