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| ID | Type | Description | Link |
|---|---|---|---|
| 09-EI-0075 | Other Identifier | National Eye Institute IRB |
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Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve 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. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC.
Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months.
Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finasteride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finasteride | Drug | Participants received 5mg of oral finasteride daily for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity at Month 3 Compared to Baseline. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity at Month 6 Compared to Baseline | 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. | 6 months |
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Participant-Level Inclusion Criteria
Participant must be 18 years of age or older.
Participant must understand and sign the protocol's informed consent document.
Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo monthly pregnancy tests throughout the study.
Female participants of childbearing potential must agree to practice two* acceptable methods of birth control throughout the course of the study and for three months after their last oral dose of finasteride. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).
*Participants with hysterectomy or vasectomy are exempt from using two methods of birth control. However female participants with a tubal ligation are not exempt and are required to practice another acceptable method of birth control.
Participant agrees to take the appropriate precautions to ensure that persons who are pregnant, nursing or of childbearing potential do not handle the finasteride tablets.
Participant-Level Exclusion Criteria
Study Eye Inclusion Criteria
Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria:
Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
Participant must have visual acuity between 20/25 and 20/400 in the study eye.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine B Meyerle, MD | 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 | All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Finasteride |
| 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 | Change in Visual Acuity at Month 3 Compared to Baseline. | 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. | Posted | Apr 2011 | Mean | Standard Deviation | ETDRS letters | 3 months |
|
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1 year
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Libido decreased | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine M. Meyerle, MD | National Eye Institute | 301-435-7821 | meyerlec@nei.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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| Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline | 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. | 3 months |
| Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline | 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. | 6 months |
| Change in Subretinal Fluid Volume at Month 3 Compared to Baseline | 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. | 3 Months |
| Change in Subretinal Fluid Volume at Month 6 Compared to Baseline | 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. | 6 Months |
| Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | 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. | 3 Months |
| Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline | 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. | 6 Months |
| Change in Serum Testosterone Level at Month 3 Compared to Baseline | 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. | 3 Months |
| Change in Serum Testosterone Level at Month 6 Compared to Baseline | 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. | 6 Months |
| Change in Urinary Cortisol Level at Month 3 Compared to Baseline | The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms. | 3 Months |
| Change in Urinary Cortisol Level at Month 6 Compared to Baseline | The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms. | 6 Months |
| 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. |
| 21273946 | Result | Forooghian F, Meleth AD, Cukras C, Chew EY, Wong WT, Meyerle CB. Finasteride for chronic central serous chorioretinopathy. Retina. 2011 Apr;31(4):766-71. doi: 10.1097/IAE.0b013e3181f04a35. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Visual Acuity at Month 6 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | ETDRS letters | 6 months |
|
|
|
| Secondary | Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | µm | 3 months |
|
|
|
| Secondary | Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | µm | 6 months |
|
|
|
| Secondary | Change in Subretinal Fluid Volume at Month 3 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | µL | 3 Months |
|
|
|
| Secondary | Change in Subretinal Fluid Volume at Month 6 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | µL | 6 Months |
|
|
|
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | pg/mL | 3 Months |
|
|
|
| Secondary | Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline | 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. | Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis. | Posted | Apr 2011 | Mean | Standard Deviation | pg/mL | 6 Months |
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|
| Secondary | Change in Serum Testosterone Level at Month 3 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | ng/dL | 3 Months |
|
|
|
| Secondary | Change in Serum Testosterone Level at Month 6 Compared to Baseline | 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. | Posted | Apr 2011 | Mean | Standard Deviation | ng/dL | 6 Months |
|
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|
| Secondary | Change in Urinary Cortisol Level at Month 3 Compared to Baseline | The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms. | Posted | Apr 2011 | Mean | Standard Deviation | µg | 3 Months |
|
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| Secondary | Change in Urinary Cortisol Level at Month 6 Compared to Baseline | The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms. | Posted | Apr 2011 | Mean | Standard Deviation | µg | 6 Months |
|
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|
| 0 |
| 5 |
| 5 |
| 5 |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Aspartate aminotransferase decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |