Trial · NCT00837252
Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
NCT00837252, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2011-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy. Trials, record NCT00837252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00837252
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
- NCT number
- NCT00837252
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Retinal Disease
- Interventions
- Finasteride
- First posted
- 2009-02-05
- Last updated
- 2016-09-26
- Results first posted
- 2011-05-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Visual Acuity at Month 3 Compared to Baseline. | 3 months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This 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 Snellen measurement is 20/20. |
| Secondary | Change in Visual Acuity at Month 6 Compared to Baseline | 6 months | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This 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 Snellen measurement is 20/20. |
| Secondary | Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline | 3 months | Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. |
| Secondary | Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline | 6 months | Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. |
| Secondary | Change in Subretinal Fluid Volume at Month 3 Compared to Baseline | 3 Months | Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume. |
| Secondary | Change in Subretinal Fluid Volume at Month 6 Compared to Baseline | 6 Months | Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume. |
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | 3 Months | The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum. |
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline | 6 Months | The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum. |
| Secondary | Change in Serum Testosterone Level at Month 3 Compared to Baseline | 3 Months | The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum. |
| Secondary | Change in Serum Testosterone Level at Month 6 Compared to Baseline | 6 Months | The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Visual Acuity at Month 3 Compared to Baseline. | 3 months | ETDRS letters | MEAN | |
| SECONDARY | Change in Visual Acuity at Month 6 Compared to Baseline | 6 months | ETDRS letters | MEAN | |
| SECONDARY | Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline | 3 months | µm | MEAN | |
| SECONDARY | Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline | 6 months | µm | MEAN | |
| SECONDARY | Change in Subretinal Fluid Volume at Month 3 Compared to Baseline | 3 Months | µL | MEAN | |
| SECONDARY | Change in Subretinal Fluid Volume at Month 6 Compared to Baseline | 6 Months | µL | MEAN | |
| SECONDARY | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | 3 Months | pg/mL | MEAN | |
| SECONDARY | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline | 6 Months | Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis. | pg/mL | MEAN |
| SECONDARY | Change in Serum Testosterone Level at Month 3 Compared to Baseline | 3 Months | ng/dL | MEAN | |
| SECONDARY | Change in Serum Testosterone Level at Month 6 Compared to Baseline | 6 Months | ng/dL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Visual Acuity at Month 3 Compared to Baseline. | Finasteride | 0 | Standard Deviation 22 | ETDRS letters | |
| Change in Visual Acuity at Month 6 Compared to Baseline | Finasteride | -3 | Standard Deviation 23 | ETDRS letters | |
| Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline | Finasteride | -86 | Standard Deviation 105 | µm | |
| Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline | Finasteride | -69 | Standard Deviation 103 | µm | |
| Change in Subretinal Fluid Volume at Month 3 Compared to Baseline | Finasteride | -0.58 | Standard Deviation 0.71 | µL | |
| Change in Subretinal Fluid Volume at Month 6 Compared to Baseline | Finasteride | -0.53 | Standard Deviation 0.72 | µL | |
| Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | Finasteride | -246 | Standard Deviation 116 | pg/mL | |
| Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline | Finasteride | -296 | Standard Deviation 87 | pg/mL | |
| Change in Serum Testosterone Level at Month 3 Compared to Baseline | Finasteride | 0.38 | Standard Deviation 3.63 | ng/dL | |
| Change in Serum Testosterone Level at Month 6 Compared to Baseline | Finasteride | -0.4 | Standard Deviation 3.38 | ng/dL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finasteride | 5 | |
| Overall Study | COMPLETED | Finasteride | 5 | |
| Overall Study | NOT COMPLETED | Finasteride | 0 |
Source ClinicalTrials.gov
Adverse events17
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 | Libido decreased | Psychiatric disorders | Finasteride | 2 | 5 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Finasteride | 1 | 5 | 1 |
| other | Viral infection | Infections and infestations | Finasteride | 1 | 5 | 1 |
| other | Alanine aminotransferase increased | Investigations | Finasteride | 1 | 5 | 1 |
| other | Heart rate increased | Investigations | Finasteride | 1 | 5 | 1 |
| other | Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Finasteride | 1 | 5 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Finasteride | 1 | 5 | 1 |
| other | Influenza like illness | General disorders | Finasteride | 1 | 5 | 1 |
| other | Blood pressure increased | Investigations | Finasteride | 2 | 5 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Finasteride | 1 | 5 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse 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 | 5 | 5 |
| Total, serious adverse events | Finasteride | 0 | 5 |
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 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.
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