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

Phase 1

Completed

Conditions: Retinal Disease

Interventions: Drug: Finasteride

Registration Number: NCT00837252

Lead Sponsor: National Eye Institute (NEI)

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Finasteride	Finasteride	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Acuity at Month 3 Compared to Baseline.	3 months	Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This 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 Snellen measurement is 20/20.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity at Month 6 Compared to Baseline	6 months	Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This 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 Snellen measurement is 20/20.
Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline	3 months	Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline	6 months	Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
Change in Subretinal Fluid Volume at Month 3 Compared to Baseline	3 Months	Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume.
Change in Subretinal Fluid Volume at Month 6 Compared to Baseline	6 Months	Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume.
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline	3 Months	The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline	6 Months	The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.
Change in Serum Testosterone Level at Month 3 Compared to Baseline	3 Months	The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.
Change in Serum Testosterone Level at Month 6 Compared to Baseline	6 Months	The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.
Change in Urinary Cortisol Level at Month 3 Compared to Baseline	3 Months	The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.
Change in Urinary Cortisol Level at Month 6 Compared to Baseline	6 Months	The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.