Retinal DiseasePhase 2NCT01585441
Finasteride for Chronic Central Serous Chorioretinopathy
A Phase 2 study testing Finasteride in people with Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase II, Randomized, Placebo-Controlled Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
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.
Read more
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.
Read the 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.
- Conditions
- Retinal Disease
- Being tested
- Finasteride, Placebo
- Keywords
- Finasteride, Central Serous Chorioretinopathy
- Medical subject headings
- Retinal Diseases, Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinasterideDrug
Also called Propecia®, Proscar®
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.
PlaceboDrug
Capsule with no active ingredients to mimic finasteride
| Study group | Role | What they receive |
|---|---|---|
| Finasteride 5 mg | Experimental | Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. Receives: Drug: Finasteride |
| Placebo | Placebo comparator | Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 3
Secondary outcomes (21)
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.
Measured: Duration of the study, up to 1.5 years
Number of Participants Who Withdrew From the Study
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: Month 3
Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline
Microperimetry was used to assess macular sensitivity.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Final Study Visit
Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline
The mean change is reported in micrograms (μg).
Measured: Month 3
Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline
The mean change is reported in micrograms (μg).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Final Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: This study was terminated early due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Emily Y Chew, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585441
- Sponsor's protocol ID
- 120119
- Other IDs
- 12-EI-0119
- Status last verified
- Nov 2014
- First submitted
- 24 Apr 2012
- Last updated
- 4 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.
PubMed 2469527Tewari 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.
PubMed 16877418Spahn 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.
PubMed 12770965Lange 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.
PubMed 40522203
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Placebo-Controlled Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01585441
- Acronym / sponsor ID
- 120119
- Conditions
- Retinal Disease
- Keywords
- Finasteride, Central Serous Chorioretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to lack of enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Posted 4 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finasteride 5 mg | Experimental | Drug: FinasterideParticipants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomly assigned to the placebo arm will instructed to take one capsule daily for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinasterideAlso: Propecia®, Proscar®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. | Drug | Finasteride 5 mg |
| PlaceboCapsule with no active ingredients to mimic finasteride | Drug | Placebo |
Primary outcome
Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.
Time frame: 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.
Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline
Time frame: 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.
21 secondary outcomes
Number of Participants With Adverse Reactions Related to the Investigational Product
Time frame: Duration of the study, up to 1.5 years
Number of Participants Who Withdrew From the Study
Time frame: 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
Time frame: Month 3
Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline
Time frame: Month 3
Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline
Time frame: Month 3
Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline
Time frame: Month 3
Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline
Time frame: Month 3
Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Change in Serum Testosterone Concentration at Month 3 Compared to Baseline
Time frame: Month 3
Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline
Time frame: Month 3
Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline
Time frame: Month 3
Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline
Time frame: 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
Time frame: 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
Time frame: Final Study Visit
Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline
Time frame: Month 3
Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline
Time frame: Final Study Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2469527Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.
- Background: PubMed 16877418Tewari 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.
- Background: PubMed 12770965Spahn 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.
- Derived from this study: PubMed 40522203Lange 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Y Chew, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finasteride in people with Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585441, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014; AzTrials last refreshed its copy on 31 Oct 2026.