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Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Primary Purpose

Retinal Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Finasteride
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Disease focused on measuring Central Serous Chorioretinopathy, Finasteride, Proscar, Retinal Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participant-Level Inclusion Criteria

  1. Participant must be 18 years of age or older.
  2. Participant must understand and sign the protocol's informed consent document.
  3. 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.
  4. 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.

  5. 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

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant is unable to comply with study procedures or follow-up visits.
  3. Participant has evidence of ocular disease other than CSC in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.).
  4. Participant has evidence of CNV.
  5. Participant has abnormal liver function testing as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN), i.e., ALT > 82 U/L and/or AST > 68 U/L. If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled if cleared by hepatology.
  6. Participant is expected to need ocular surgery during the course of the trial.
  7. Participant is on steroid medication (oral, topical or inhaled).
  8. Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve.
  9. Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Study Eye Inclusion Criteria

  1. Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria:

    1. The presence of subretinal fluid, as determined by spectral domain OCT, AND
    2. The subretinal fluid must have been present for at least three months, or there is a recurrence of subretinal fluid within the past three months, AND
    3. The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy. This eye will be referred to as the "study eye."
  2. Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
  3. Participant must have visual acuity between 20/25 and 20/400 in the study eye.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Finasteride

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2009
Last Updated
September 22, 2016
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00837252
Brief Title
Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Official Title
Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease
Keywords
Central Serous Chorioretinopathy, Finasteride, Proscar, Retinal Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Finasteride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Propecia, Proscar
Intervention Description
Participants received 5mg of oral finasteride daily for three months.
Primary Outcome Measure Information:
Title
Change in Visual Acuity at Month 3 Compared to Baseline.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Visual Acuity at Month 6 Compared to Baseline
Description
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.
Time Frame
6 months
Title
Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline
Description
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.
Time Frame
3 months
Title
Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline
Description
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.
Time Frame
6 months
Title
Change in Subretinal Fluid Volume at Month 3 Compared to Baseline
Description
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.
Time Frame
3 Months
Title
Change in Subretinal Fluid Volume at Month 6 Compared to Baseline
Description
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.
Time Frame
6 Months
Title
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline
Description
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.
Time Frame
3 Months
Title
Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline
Description
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.
Time Frame
6 Months
Title
Change in Serum Testosterone Level at Month 3 Compared to Baseline
Description
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.
Time Frame
3 Months
Title
Change in Serum Testosterone Level at Month 6 Compared to Baseline
Description
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.
Time Frame
6 Months
Title
Change in Urinary Cortisol Level at Month 3 Compared to Baseline
Description
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.
Time Frame
3 Months
Title
Change in Urinary Cortisol Level at Month 6 Compared to Baseline
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Participant is in another investigational study and actively receiving study therapy. Participant is unable to comply with study procedures or follow-up visits. Participant has evidence of ocular disease other than CSC in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.). Participant has evidence of CNV. Participant has abnormal liver function testing as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN), i.e., ALT > 82 U/L and/or AST > 68 U/L. If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled if cleared by hepatology. Participant is expected to need ocular surgery during the course of the trial. Participant is on steroid medication (oral, topical or inhaled). Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve. Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Study Eye Inclusion Criteria Eligible participants must have chronic CSC in at least one eye as defined by all of the following criteria: The presence of subretinal fluid, as determined by spectral domain OCT, AND The subretinal fluid must have been present for at least three months, or there is a recurrence of subretinal fluid within the past three months, AND The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy. This eye will be referred to as the "study eye." 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine B Meyerle, MD
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2469527
Citation
Gomolin JE. Choroidal neovascularization and central serous chorioretinopathy. Can J Ophthalmol. 1989 Feb;24(1):20-3.
Results Reference
background
PubMed Identifier
16877418
Citation
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.
Results Reference
background
PubMed Identifier
12770965
Citation
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.
Results Reference
background
PubMed Identifier
21273946
Citation
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.
Results Reference
result

Learn more about this trial

Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

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