Clinical trial NCT00837252: Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Official title: Pilot 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: 2009-02-05
Enrollment: 5
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: Central serous chorioretinopathy (CSC) is a retinal 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 have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC.

Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months.

Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.


Eligibility criteria: Participant-Level Inclusion Criteria

1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol's informed consent document.
3. Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo monthly pregnancy tests throughout the study.
4. Female participants of childbearing potential must agree to practice two\* acceptable methods of birth control throughout the course of the study and for three months after their last oral dose of finasteride. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).

   \*Participants with hysterectomy or vasectomy are exempt from using two methods of birth control. However female participants with a tubal ligation are not exempt and are required to practice another acceptable method of birth control.
5. 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.

Participant-Level Exclusion Criteria

1. Participant is in another investigational study and actively receiving study therapy.
2. Participant is unable to comply with study procedures or follow-up visits.
3. Participant has evidence of ocular disease other than CSC in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.).
4. Participant has evidence of CNV.
5. Participant has abnormal liver function testing 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 \> 82 U/L and/or AST \> 68 U/L. If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled if cleared by hepatology.
6. Participant is expected to need ocular surgery during the course of the trial.
7. Participant is on steroid medication (oral, topical or inhaled).
8. Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve.
9. Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Study Eye Inclusion Criteria

1. Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria:

   1. The presence of subretinal fluid, as determined by spectral domain OCT, AND
   2. The subretinal fluid must have been present for at least three months, or there is a recurrence of subretinal fluid within the past three months, AND
   3. The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy. This eye will be referred to as the "study eye."
2. Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
3. Participant must have visual acuity between 20/25 and 20/400 in the study eye.

Primary outcomes:
measure: Change in Visual Acuity at Month 3 Compared to Baseline.
timeFrame: 3 months
Secondary outcomes:
measure: Change in Visual Acuity at Month 6 Compared to Baseline
timeFrame: 6 months
measure: Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline
timeFrame: 3 months
measure: Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline
timeFrame: 6 months
measure: Change in Subretinal Fluid Volume at Month 3 Compared to Baseline
timeFrame: 3 Months
measure: Change in Subretinal Fluid Volume at Month 6 Compared to Baseline
timeFrame: 6 Months
measure: Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline
timeFrame: 3 Months
measure: Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline
timeFrame: 6 Months
measure: Change in Serum Testosterone Level at Month 3 Compared to Baseline
timeFrame: 3 Months
measure: Change in Serum Testosterone Level at Month 6 Compared to Baseline
timeFrame: 6 Months
measure: Change in Urinary Cortisol Level at Month 3 Compared to Baseline
timeFrame: 3 Months
measure: Change in Urinary Cortisol Level at Month 6 Compared to Baseline
timeFrame: 6 Months
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 B Meyerle, MD
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.
citation: Forooghian F, Meleth AD, Cukras C, Chew EY, Wong WT, Meyerle CB. Finasteride for chronic central serous chorioretinopathy. Retina. 2011 Apr;31(4):766-71. doi: 10.1097/IAE.0b013e3181f04a35.