Trial · NCT01227993
Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
NCT01227993, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2013-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy. Trials, record NCT01227993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
- NCT number
- NCT01227993
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Retinal Disease
- Interventions
- Finasteride
- First posted
- 2010-10-25
- Last updated
- 2024-01-30
- Results first posted
- 2013-09-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline | Baseline and 2 years | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline | Baseline and 2 years | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline | Baseline and 1 year | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline | Baseline and 1 year | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Serum Testosterone Levels at Two Years Compared to Baseline | Baseline and 2 years | The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum. |
| Secondary | Change in Serum DHT Levels at Two Years Compared to Baseline | Baseline and 2 years | The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum. |
| Secondary | Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline | Baseline and 2 years | The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms. |
| Secondary | Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline | Baseline and 2 years | |
| Secondary | Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline | Baseline and 2 years | |
| Secondary | Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline | Baseline and 2 years |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline | Baseline and 2 years | ETDRS letters | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline | Baseline and 2 years | ETDRS letters | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline | Baseline and 1 year | ETDRS letters | MEAN | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline | Baseline and 1 year | ETDRS letters | MEAN | |
| SECONDARY | Change in Serum Testosterone Levels at Two Years Compared to Baseline | Baseline and 2 years | ng/dL | MEAN | |
| SECONDARY | Change in Serum DHT Levels at Two Years Compared to Baseline | Baseline and 2 years | pg/mL | MEAN | |
| SECONDARY | Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline | Baseline and 2 years | µg | MEAN | |
| SECONDARY | Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline | Baseline and 2 years | Due to lack of effect in other outcome measures, at investigator's discretion, data for this outcome measure was neither collected nor analyzed. As such, zero participants have data for this outcome. | ||
| SECONDARY | Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline | Baseline and 2 years | Due to lack of effect in other outcome measures, at investigator's discretion, data for this outcome measure was neither collected nor analyzed. As such, zero participants have data for this outcome. | ||
| SECONDARY | Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline | Baseline and 2 years | Due to lack of effect in other outcome measures, at investigator's discretion, data for this outcome measure was neither collected nor analyzed. As such, zero participants have data for this outcome. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline | Finasteride | 0 | Standard Deviation 5.20 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline | Finasteride | -1.00 | Standard Deviation 5.29 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline | Finasteride | 0 | Standard Deviation 4.58 | ETDRS letters | |
| Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline | Finasteride | 0.33 | Standard Deviation 4.16 | ETDRS letters | |
| Change in Serum Testosterone Levels at Two Years Compared to Baseline | Finasteride | -28.67 | Standard Deviation 144.05 | ng/dL | |
| Change in Serum DHT Levels at Two Years Compared to Baseline | Finasteride | 10.67 | Standard Deviation 44.06 | pg/mL | |
| Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline | Finasteride | 2.75 | Standard Deviation 5.16 | µg |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finasteride | 3 | |
| Overall Study | COMPLETED | Finasteride | 3 | |
| Overall Study | NOT COMPLETED | Finasteride | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Alanine aminotransferase increased | Investigations | Finasteride | 1 | 3 | 1 |
| other | Aspartate aminotrasferase increased | Investigations | Finasteride | 1 | 3 | 1 |
| other | Bronchitis | Infections and infestations | Finasteride | 1 | 3 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Finasteride | 1 | 3 | 1 |
| other | Libido decreased | Psychiatric disorders | Finasteride | 1 | 3 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Finasteride | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finasteride | ||
| Total, other adverse events | Finasteride | 3 | 3 |
| Total, serious adverse events | Finasteride | 0 | 3 |
Source ClinicalTrials.gov
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01227993
GET https://conductscience.org/api/trials/v1/NCT01227993/registered