Finasteride for Chronic Central Serous Chorioretinopathy

• Sponsor: National Eye Institute (NEI) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT01585441
• Collaborator: The Emmes Company, LLC (Industry)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Background:

• Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under the retina. It affects the macula, which is in the center of the retina and is needed for sharp, clear vision. In many cases, CSC resolves on its own and does not need treatment. However, in some cases it does not go away or comes back after treatment. This is known as chronic CSC.

• Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can alter the effects certain of androgens. Researchers want to compare finasteride with a placebo to see if it is a safe and effective treatment for chronic CSC.

Objectives:

• To see if finasteride is a safe and effective treatment for chronic CSC.

Eligibility:

• Individuals at least 18 years of age who have chronic CSC in one or both eyes.

Design:

• Participants will be screened with a physical exam and medical history. A full eye exam will be performed. Blood and urine samples will also be collected.

• Some participants may have photodynamic therapy (PDT), the standard treatment for CSC. PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3 months after PDT before starting the finasteride study.

• Participants will be separated into two groups. One group will take finasteride 5 mg (formulated into capsules); the other group will take a placebo capsule. All participants will take the capsules for 3 months.

• After 3 months on the assigned capsule (finasteride or placebo), all participants will have the opportunity to take finasteride for at least another 4 years and 9 months. This phase of the study is optional.

• Participants will have regular study visits. At each visit, they will have physical exams and eye exams. They will also provide blood and urine samples.

• During the first 3 months, participants will have 2 study visits. After 3 months, if the participant continues in the optional (or as needed) phase of the protocol, visits will occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits may be needed.

Condition or Disease	Intervention/Treatment	Phase
Retinal Disease	Drug: Finasteride; Drug: Placebo	Phase 2

Detailed Description

Objective:

Central serous chorioretinopathy (CSC) is a chorioretinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to resolve spontaneously 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. A previous study performed at the NEI demonstrated a reduction in the amount of subretinal fluid among participants treated with 5 mg of finasteride. The objective of this study is to further investigate the efficacy of oral finasteride as a treatment for chronic CSC.

Study Population:

Thirty-eight participants with chronic CSC are eligible. Up to an additional four participants may be enrolled to account for participants who withdraw from the study prior to Month 3.

Design:

In this Phase II, single-center, placebo-controlled, double-masked, randomized trial, investigational product will be administered to two different groups. Half of the participants will be randomized to 5 mg oral finasteride for the initial three months. The other half of the participants will be randomized to placebo for the first three months. At the end of three months of treatment, all participants may be followed for at least four years and nine months. During this follow-up period, all participants will be able to receive finasteride therapy pro re nata (PRN) if subretinal fluid re-emerges. The PRN phase will last until the last participant completes the five years of follow-up. Other standard care treatments, such as photodynamic therapy, will also be permitted after the primary outcome at three months.

Outcome Measures:

The primary outcome for regulatory filing is the proportion of participants with an improvement in best-corrected visual acuity (BCVA) ≥ 15 letters at three months compared to baseline in the study eye. The primary outcome for publication of the study results is the proportion of participants with a subretinal fluid volume decrease ≥ 50% at three months compared to baseline in the study eye. Secondary efficacy outcomes include changes in BCVA, changes in the maximum retinal volume as measured on optical coherence tomography (OCT), changes in central retinal thickness on OCT, changes in leakage as seen on fluorescein angiography (FA), changes in size of existing plaque(s) on indocyanine green (ICG) angiography, changes in autofluorescence patterns seen on fundus autofluorescence (FAF) imaging, changes in mean macular sensitivity as assessed by microperimetry, changes in serum levels of testosterone and dihydrotestosterone (DHT), as well as changes in urine levels of cortisol during the study period. Safety outcomes include the number and severity of adverse reactions from the investigational product and the number of withdrawals.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase II, Randomized, Placebo-Controlled Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Finasteride 5 mg Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.	Drug: Finasteride; Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.; Other Names: Propecia® Proscar®
Placebo Comparator: Placebo Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.	Drug: Placebo; Capsule with no active ingredients to mimic finasteride

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. [Month 3]

   This is the regulatory filing primary outcome measure. 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.

2. Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline [Month 3]

   This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.

Secondary Outcome Measures

1. Number of Participants With Adverse Reactions Related to the Investigational Product [Duration of the study, up to 1.5 years]

   The outcome measure refers only to events that were classified as related to the investigational product.

2. Number of Participants Who Withdrew From the Study [Duration of the study, up to 1.5 years]

3. Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline [Month 3]

   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. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

4. Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline [Final Study Visit]

   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. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

5. Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline [Month 3]

   Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.

6. Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline [Month 3]

   Microperimetry was used to assess macular sensitivity.

7. Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline [Final Study Visit]

   Microperimetry was used to assess macular sensitivity.

8. Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline [Month 3]

   Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).

9. Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline [Final Study Visit]

   Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).

10. Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline [Month 3]

    The mean change is reported in picograms of DHT per milliliter of serum.

11. Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline [Final Study Visit]

    The mean change is reported in picograms of DHT per milliliter of serum.

12. Change in Serum Testosterone Concentration at Month 3 Compared to Baseline [Month 3]

    The mean change is reported in nanograms of testosterone per decaliter of serum.

13. Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline [Final Study Visit]

    The mean change is reported in nanograms of testosterone per decaliter of serum.

14. Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline [Month 3]

    The mean change is reported in micrograms (μg).

15. Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline [Final Study Visit]

    The mean change is reported in micrograms (μg).

16. Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline [Month 3]

    Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging

17. Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline [Final Study Visit]

    Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging

18. Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline [Month 3]

19. Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline [Final Study Visit]

20. Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline [Month 3]

    Changes in leakage as observed on fluorescein angiography (FA)

21. Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline [Final Study Visit]

    Changes in leakage as observed on fluorescein angiography (FA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

• Participant must have chronic Central Serous Chorioretinopathy (CSC) in at least one eye as defined by all of the following criteria. This eye will be referred to as the study eye.

• The presence of subretinal fluid, as determined by optical coherence tomography (OCT), AND

• The subretinal fluid must have been present for at least three months or recurrent in cases of chronic CSC/diffuse retinal pigment epitheliopathy, AND/OR

• The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy noted on fluorescein or descending tract lesions on autofluorescence.

• Participant must have a steady fixation in the study eye.

• Participant must have media clear enough in the foveal or parafoveal area in the study eye for good quality photographs.

• Participant must have visual acuity between 20/25 and 20/400 in the study eye.

EXCLUSION CRITERIA:

• Participant has evidence of choroidal neovascularization (CNV) in the study eye.

• Participant is expected to need ocular surgery in the study eye during the first three months of the study.

• Participant has had photodynamic therapy (PDT) or focal laser treatment in the study eye within three months prior to enrollment or is expected to need PDT or focal laser treatment in the study eye during the first three months of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Eye Institute (NEI)
• The Emmes Company, LLC

Investigators

• Principal Investigator: Emily Y Chew, M.D., National Eye Institute (NEI)

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.
• 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.
• 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.

• Responsible Party: National Eye Institute (NEI)
• ClinicalTrials.gov Identifier: NCT01585441
• Other Study ID Numbers: 120119; 12-EI-0119
• First Posted: Apr 25, 2012
• Last Update Posted: Dec 4, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by National Eye Institute (NEI): Finasteride; Central Serous Chorioretinopathy
• Additional relevant MeSH terms: Retinal Diseases; Central Serous Chorioretinopathy; Finasteride

Study Results

Participant Flow

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Period Title: Overall Study
STARTED	3	3
Month 3	2	3
Received Finasteride at Month 3	2	2
Final Study Safety Visit	3	2
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Finasteride 5 mg	Placebo	Total
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride	Total of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 33.3%	2 66.7%	3 50%
>=65 years	2 66.7%	1 33.3%	3 50%
Sex: Female, Male (Count of Participants)
Female	1 33.3%	0 0%	1 16.7%
Male	2 66.7%	3 100%	5 83.3%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.
Description	This is the regulatory filing primary outcome measure. 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.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Number [participants]	0 0%	0 0%

2. Primary Outcome

Title	Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline
Description	This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Number [participants]	1 33.3%	0 0%

3. Secondary Outcome

Title	Number of Participants With Adverse Reactions Related to the Investigational Product
Description	The outcome measure refers only to events that were classified as related to the investigational product.
Time Frame	Duration of the study, up to 1.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	3
Number [participants]	0 0%	1 33.3%

4. Secondary Outcome

Title	Number of Participants Who Withdrew From the Study
Time Frame	Duration of the study, up to 1.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	3
Number [participants]	0 0%	0 0%

5. Secondary Outcome

Title	Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline
Description	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. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Mean (Standard Deviation) [ETDRS letters]	1.00 (1.41)	1.67 (2.08)

6. Secondary Outcome

Title	Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline
Description	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. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Measure Eyes	3	2
Mean (Standard Deviation) [ETDRS letters]	-3.33 (8.39)	0.50 (0.71)

7. Secondary Outcome

Title	Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline
Description	Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the "Edit Segmentation" function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Mean (Standard Deviation) [percent change]	-37.50 (53.03)	27.78 (63.10)

8. Secondary Outcome

Title	Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline
Description	Microperimetry was used to assess macular sensitivity.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Mean (Standard Deviation) [decibels]	-2.00 (3.82)	-1.40 (1.47)

9. Secondary Outcome

Title	Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline
Description	Microperimetry was used to assess macular sensitivity.
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Measure Eyes	3	2
Mean (Standard Deviation) [decibels]	-2.03 (3.91)	-2.45 (0.50)

10. Secondary Outcome

Title	Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline
Description	Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Measure Eyes	2	3
Mean (Standard Deviation) [μm]	-55.00 (50.91)	20.33 (72.59)

11. Secondary Outcome

Title	Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline
Description	Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Measure Eyes	3	2
Mean (Standard Deviation) [μm]	-39.67 (93.30)	50.50 (41.72)

12. Secondary Outcome

Title	Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline
Description	The mean change is reported in picograms of DHT per milliliter of serum.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Mean (Standard Deviation) [pg/mL]	-332.00 (176.78)	-93.67 (113.50)

13. Secondary Outcome

Title	Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline
Description	The mean change is reported in picograms of DHT per milliliter of serum.
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Mean (Standard Deviation) [pg/mL]	-101.67 (103.00)	-337.50 (467.40)

14. Secondary Outcome

Title	Change in Serum Testosterone Concentration at Month 3 Compared to Baseline
Description	The mean change is reported in nanograms of testosterone per decaliter of serum.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Mean (Standard Deviation) [ng/dL]	-33.50 (139.30)	-29.67 (111.96)

15. Secondary Outcome

Title	Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline
Description	The mean change is reported in nanograms of testosterone per decaliter of serum.
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Measure Eyes	3	2
Mean (Standard Deviation) [ng/dL]	-42.00 (194.51)	33.00 (100.41)

16. Secondary Outcome

Title	Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline
Description	The mean change is reported in micrograms (μg).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Mean (Standard Deviation) [μg]	5.75 (23.12)	-7.10 (16.71)

17. Secondary Outcome

Title	Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline
Description	The mean change is reported in micrograms (μg).
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL.

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	2
Mean (Standard Deviation) [μg]	-0.60 (3.53)	0.70 (6.08)

18. Secondary Outcome

Title	Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline
Description	Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Number [participants]	2 66.7%	3 100%

19. Secondary Outcome

Title	Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline
Description	Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Number [participants]	3 100%	2 66.7%

20. Secondary Outcome

Title	Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Number [participants]	2 66.7%	3 100%

21. Secondary Outcome

Title	Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Number [participants]	3 100%	2 66.7%

22. Secondary Outcome

Title	Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline
Description	Changes in leakage as observed on fluorescein angiography (FA)
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	2	3
Number [participants]	2 66.7%	2 66.7%

23. Secondary Outcome

Title	Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline
Description	Changes in leakage as observed on fluorescein angiography (FA)
Time Frame	Final Study Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride 5 mg	Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.	Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
Measure Participants	3	2
Number [participants]	2 66.7%	2 66.7%

Adverse Events

Time Frame	Duration of the study, up to 1.5 years
Arm/Group Title	Finasteride 5 mg		Placebo
Arm/Group Description	Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.		Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Placebo: Capsule with no active ingredients to mimic finasteride
All Cause Mortality
	Finasteride 5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Finasteride 5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Finasteride 5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		1/3 (33.3%)
Eye disorders
Eye pruritis	1/3 (33.3%)	1	0/3 (0%)	0
Injury, poisoning and procedural complications
Ankle Fracture	1/3 (33.3%)	1	0/3 (0%)	0
Nervous system disorders
Dizziness	2/3 (66.7%)	2	0/3 (0%)	0
Headache	1/3 (33.3%)	1	0/3 (0%)	0
Reproductive system and breast disorders
Erectile Dysfunction	0/3 (0%)	0	1/3 (33.3%)	1

Limitations/Caveats

This study was terminated early due to lack of enrollment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.