Trial Outcomes & Findings for Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy (NCT NCT00837252)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

3 months

Results posted on

2016-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Finasteride All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Finasteride n=5 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	50 years STANDARD_DEVIATION 10.4 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Visual Acuity at Month 3 Compared to Baseline.	0 ETDRS letters Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Visual Acuity at Month 6 Compared to Baseline	-3 ETDRS letters Standard Deviation 23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline	-86 µm Standard Deviation 105

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline	-69 µm Standard Deviation 103

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Subretinal Fluid Volume at Month 3 Compared to Baseline	-0.58 µL Standard Deviation 0.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Subretinal Fluid Volume at Month 6 Compared to Baseline	-0.53 µL Standard Deviation 0.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline	-246 pg/mL Standard Deviation 116

SECONDARY outcome

Timeframe: 6 Months

Population: Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Finasteride n=3 Participants
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline	-296 pg/mL Standard Deviation 87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Serum Testosterone Level at Month 3 Compared to Baseline	0.38 ng/dL Standard Deviation 3.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Serum Testosterone Level at Month 6 Compared to Baseline	-0.4 ng/dL Standard Deviation 3.38

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Urinary Cortisol Level at Month 3 Compared to Baseline	3 µg Standard Deviation 24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Finasteride n=5 Participants
Change in Urinary Cortisol Level at Month 6 Compared to Baseline	-2 µg Standard Deviation 18

Adverse Events

Finasteride

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Finasteride n=5 participants at risk
Psychiatric disorders Libido decreased	40.0% 2/5 • Number of events 2 • 1 year
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Number of events 1 • 1 year
Infections and infestations Viral infection	20.0% 1/5 • Number of events 1 • 1 year
Investigations Alanine aminotransferase increased	20.0% 1/5 • Number of events 1 • 1 year
Investigations Heart rate increased	20.0% 1/5 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	20.0% 1/5 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • Number of events 1 • 1 year
General disorders Influenza like illness	20.0% 1/5 • Number of events 1 • 1 year
Investigations Blood pressure increased	40.0% 2/5 • Number of events 2 • 1 year
Infections and infestations Upper respiratory tract infection	20.0% 1/5 • Number of events 1 • 1 year
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • 1 year
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • Number of events 1 • 1 year
Vascular disorders Hypotension	20.0% 1/5 • Number of events 1 • 1 year
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • 1 year
Investigations White blood cell count decreased	20.0% 1/5 • Number of events 1 • 1 year
Blood and lymphatic system disorders Leukopenia	20.0% 1/5 • Number of events 1 • 1 year
Investigations Aspartate aminotransferase decreased	20.0% 1/5 • Number of events 1 • 1 year

Additional Information

Catherine M. Meyerle, MD

National Eye Institute

Phone: 301-435-7821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place