National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
NCT Number: NCT00837252
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Bethesda, Maryland, 20892, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participant-Level Inclusion Criteria
*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.
Participant-Level Exclusion Criteria
Study Eye Inclusion Criteria
Participants received 5mg of oral finasteride daily for three months.
Other names: Propecia, Proscar
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
National Eye Institute (NEI)
Nih
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01468337
Central Serous Chorioretinopathy, Eye Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01227993
Central Serous Chorioretinopathy, Eye Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT00005784
Cardiovascular Diseases, Central Serous Chorioretinopathy
Bethesda, Maryland, United States
View Trial DetailsNCT03076697
Age Related Macular Degeneration, Cardiovascular Diseases
View Trial Details