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| ID | Type | Description | Link |
|---|---|---|---|
| 12-EI-0119 |
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This study was terminated early due to lack of enrollment.
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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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Background:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finasteride 5 mg | Experimental | Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. |
|
| Placebo | Placebo Comparator | Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finasteride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | 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. | Month 3 |
| Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | 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. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Reactions Related to the Investigational Product | The outcome measure refers only to events that were classified as related to the investigational product. | Duration of the study, up to 1.5 years |
| Number of Participants Who Withdrew From the Study |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Y Chew, M.D. | National Eye Institute (NEI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2469527 | Background | Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3. | |
| 16877418 | Background | 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. doi: 10.1167/iovs.05-1246. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Finasteride 5 mg | 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. |
| FG001 | Placebo | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Finasteride 5 mg | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | 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. | Posted | Number | participants | Month 3 | Eyes | Participants |
|
Duration of the study, up to 1.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Finasteride 5 mg | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 15.0; 16.0 | Systematic Assessment |
This study was terminated early due to lack of enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Chew, MD | National Eye Institute | 301-496-6583 | emily.chew@nih.gov |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D056833 | Central Serous Chorioretinopathy |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo | Drug | Capsule with no active ingredients to mimic finasteride |
|
| Duration of the study, up to 1.5 years |
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | 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. | Month 3 |
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline | 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. | Final Study Visit |
| Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline | 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 Cirrusâ„¢ 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. | Month 3 |
| Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline | Microperimetry was used to assess macular sensitivity. | Month 3 |
| Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline | Microperimetry was used to assess macular sensitivity. | Final Study Visit |
| Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). | Month 3 |
| Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). | Final Study Visit |
| Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | The mean change is reported in picograms of DHT per milliliter of serum. | Month 3 |
| Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline | The mean change is reported in picograms of DHT per milliliter of serum. | Final Study Visit |
| Change in Serum Testosterone Concentration at Month 3 Compared to Baseline | The mean change is reported in nanograms of testosterone per decaliter of serum. | Month 3 |
| Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline | The mean change is reported in nanograms of testosterone per decaliter of serum. | Final Study Visit |
| Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline | The mean change is reported in micrograms (μg). | Month 3 |
| Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline | The mean change is reported in micrograms (μg). | Final Study Visit |
| Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging | Month 3 |
| Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging | Final Study Visit |
| 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 |
| 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 |
| Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline | Changes in leakage as observed on fluorescein angiography (FA) | Month 3 |
| Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline | Changes in leakage as observed on fluorescein angiography (FA) | Final Study Visit |
| 12770965 | Background | 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. doi: 10.1136/bjo.87.6.704. |
| 40522203 | Derived | Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3. |
| BG001 | Placebo | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | 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 |
|
|
| Primary | Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | 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. | Posted | Number | participants | Month 3 | Eyes | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Reactions Related to the Investigational Product | The outcome measure refers only to events that were classified as related to the investigational product. | Posted | Number | participants | Duration of the study, up to 1.5 years |
|
|
|
| Secondary | Number of Participants Who Withdrew From the Study | Posted | Number | participants | Duration of the study, up to 1.5 years |
|
|
|
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | 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. | Posted | Mean | Standard Deviation | ETDRS letters | Month 3 | Eyes | Participants |
|
|
|
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline | 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. | Posted | Mean | Standard Deviation | ETDRS letters | Final Study Visit | Eyes | Participants |
|
|
|
| Secondary | Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline | 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 Cirrusâ„¢ 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. | Posted | Mean | Standard Deviation | percent change | Month 3 | Eyes | Participants |
|
|
|
| Secondary | Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline | Microperimetry was used to assess macular sensitivity. | Posted | Mean | Standard Deviation | decibels | Month 3 | Eyes | Participants |
|
|
|
| Secondary | Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline | Microperimetry was used to assess macular sensitivity. | Posted | Mean | Standard Deviation | decibels | Final Study Visit | Eyes | Participants |
|
|
|
| Secondary | Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). | Posted | Mean | Standard Deviation | μm | Month 3 | Eyes | Participants |
|
|
|
| Secondary | Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline | Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT). | Posted | Mean | Standard Deviation | μm | Final Study Visit | Eyes | Participants |
|
|
|
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | The mean change is reported in picograms of DHT per milliliter of serum. | Posted | Mean | Standard Deviation | pg/mL | Month 3 |
|
|
|
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline | The mean change is reported in picograms of DHT per milliliter of serum. | Posted | Mean | Standard Deviation | pg/mL | Final Study Visit |
|
|
|
| Secondary | Change in Serum Testosterone Concentration at Month 3 Compared to Baseline | The mean change is reported in nanograms of testosterone per decaliter of serum. | Posted | Mean | Standard Deviation | ng/dL | Month 3 |
|
|
|
| Secondary | Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline | The mean change is reported in nanograms of testosterone per decaliter of serum. | Posted | Mean | Standard Deviation | ng/dL | Final Study Visit | Eyes | Participants |
|
|
|
| Secondary | Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline | The mean change is reported in micrograms (μg). | Posted | Mean | Standard Deviation | μg | Month 3 |
|
|
|
| Secondary | Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline | The mean change is reported in micrograms (μg). | One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL. | Posted | Mean | Standard Deviation | μg | Final Study Visit |
|
|
|
| Secondary | Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging | Posted | Number | participants | Month 3 |
|
|
|
| Secondary | Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline | Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging | One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit. | Posted | Number | participants | Final Study Visit |
|
|
|
| Secondary | Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline | Posted | Number | participants | Month 3 |
|
|
|
| Secondary | Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline | One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit. | Posted | Number | participants | Final Study Visit |
|
|
|
| Secondary | Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline | Changes in leakage as observed on fluorescein angiography (FA) | Posted | Number | participants | Month 3 |
|
|
|
| Secondary | Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline | Changes in leakage as observed on fluorescein angiography (FA) | Posted | Number | participants | Final Study Visit |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Placebo | 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 | 0 | 3 | 1 | 3 |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Eye pruritis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |