Trial · NCT01585441
Finasteride for Chronic Central Serous Chorioretinopathy
NCT01585441, Phase 2, Terminated, National Eye Institute (NEI); results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Finasteride for Chronic Central Serous Chorioretinopathy. Trials, record NCT01585441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Finasteride for Chronic Central Serous Chorioretinopathy
- NCT number
- NCT01585441
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Retinal Disease
- Interventions
- Finasteride, Placebo
- First posted
- 2012-04-25
- Last updated
- 2014-12-04
- Results first posted
- 2014-12-04
- Limitations and caveats
- This study was terminated early due to lack of enrollment.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | Number of Participants Who Withdrew From the Study | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline | Month 3 | Microperimetry was used to assess macular sensitivity. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | Month 3 | participants | NUMBER | |
| PRIMARY | Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | Month 3 | participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Reactions Related to the Investigational Product | Duration of the study, up to 1.5 years | participants | NUMBER | |
| SECONDARY | Number of Participants Who Withdrew From the Study | Duration of the study, up to 1.5 years | participants | NUMBER | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | Month 3 | ETDRS letters | MEAN | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline | Final Study Visit | ETDRS letters | MEAN | |
| SECONDARY | Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline | Month 3 | percent change | MEAN | |
| SECONDARY | Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline | Month 3 | decibels | MEAN | |
| SECONDARY | Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline | Final Study Visit | decibels | MEAN | |
| SECONDARY | Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline | Month 3 | μm | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | Finasteride 5 mg | 0 | participants | ||
| Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | Placebo | 0 | participants | ||
| Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | Finasteride 5 mg | 1 | participants | ||
| Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | Placebo | 0 | participants | ||
| Number of Participants With Adverse Reactions Related to the Investigational Product | Finasteride 5 mg | 0 | participants | ||
| Number of Participants With Adverse Reactions Related to the Investigational Product | Placebo | 1 | participants | ||
| Number of Participants Who Withdrew From the Study | Finasteride 5 mg | 0 | participants | ||
| Number of Participants Who Withdrew From the Study | Placebo | 0 | participants | ||
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | Finasteride 5 mg | 1.00 | Standard Deviation 1.41 | ETDRS letters | |
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline | Placebo | 1.67 | Standard Deviation 2.08 | ETDRS letters |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finasteride 5 mg | 3 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | Month 3 | Finasteride 5 mg | 2 | |
| Overall Study | Month 3 | Placebo | 3 | |
| Overall Study | Received Finasteride at Month 3 | Finasteride 5 mg | 2 | |
| Overall Study | Received Finasteride at Month 3 | Placebo | 2 | |
| Overall Study | Final Study Safety Visit | Finasteride 5 mg | 3 | |
| Overall Study | Final Study Safety Visit | Placebo | 2 | |
| Overall Study | COMPLETED | Finasteride 5 mg | 3 | |
| Overall Study | COMPLETED | Placebo | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Finasteride 5 mg | 2 | 3 | 2 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 3 | 0 |
| other | Headache | Nervous system disorders | Finasteride 5 mg | 1 | 3 | 1 |
| other | Headache | Nervous system disorders | Placebo | 0 | 3 | 0 |
| other | Eye pruritis | Eye disorders | Finasteride 5 mg | 1 | 3 | 1 |
| other | Eye pruritis | Eye disorders | Placebo | 0 | 3 | 0 |
| other | Erectile Dysfunction | Reproductive system and breast disorders | Finasteride 5 mg | 0 | 3 | 0 |
| other | Erectile Dysfunction | Reproductive system and breast disorders | Placebo | 1 | 3 | 1 |
| other | Ankle Fracture | Injury, poisoning and procedural complications | Finasteride 5 mg | 1 | 3 | 1 |
| other | Ankle Fracture | Injury, poisoning and procedural complications | Placebo | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finasteride 5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Finasteride 5 mg | 2 | 3 |
| Total, other adverse events | Placebo | 1 | 3 |
| Total, serious adverse events | Finasteride 5 mg | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Finasteride 5 mg vs Placebo: Number of Participants Who Withdrew From the Study | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants With Adverse Reactions Related to the Investigational Product | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline. | Trial comparisons |
| Finasteride 5 mg vs Placebo: Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline | Trial comparisons |
| Finasteride 5 mg vs Placebo: Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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