Trial Outcomes & Findings for Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy (NCT NCT01227993)

Results Overview

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline and 2 years

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Finasteride Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extension 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=3 Participants Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 years

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

Outcome measures

Outcome measures
Measure	Finasteride n=3 eyes Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline	0 ETDRS letters Standard Deviation 5.20

SECONDARY outcome

Timeframe: Baseline and 2 years

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

Outcome measures

Outcome measures
Measure	Finasteride n=3 eyes Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline	-1.00 ETDRS letters Standard Deviation 5.29

SECONDARY outcome

Timeframe: Baseline and 1 year

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

Outcome measures

Outcome measures
Measure	Finasteride n=3 eyes Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline	0 ETDRS letters Standard Deviation 4.58

SECONDARY outcome

Timeframe: Baseline and 1 year

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. 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 equivalent Snellen measurement is 20/20.

Outcome measures

Outcome measures
Measure	Finasteride n=3 eyes Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline	0.33 ETDRS letters Standard Deviation 4.16

SECONDARY outcome

Timeframe: Baseline and 2 years

The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.

Outcome measures

Outcome measures
Measure	Finasteride n=3 Participants Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Serum Testosterone Levels at Two Years Compared to Baseline	-28.67 ng/dL Standard Deviation 144.05

SECONDARY outcome

Timeframe: Baseline and 2 years

The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.

Outcome measures

Outcome measures
Measure	Finasteride n=3 Participants Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in Serum DHT Levels at Two Years Compared to Baseline	10.67 pg/mL Standard Deviation 44.06

SECONDARY outcome

Timeframe: Baseline and 2 years

The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.

Outcome measures

Outcome measures
Measure	Finasteride n=2 Participants Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline	2.75 µg Standard Deviation 5.16

Adverse Events

Finasteride

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Finasteride n=3 participants at risk Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1
Investigations Aspartate aminotrasferase increased	33.3% 1/3 • Number of events 1
Infections and infestations Bronchitis	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Gastrooesophageal reflux disease	33.3% 1/3 • Number of events 1
Psychiatric disorders Libido decreased	33.3% 1/3 • Number of events 1
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1

Additional Information

Catherine 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