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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00837252
First received: February 4, 2009
Last updated: May 23, 2011
Last verified: May 2011
Results First Received: April 21, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Retinal Disease
Intervention: Drug: Finasteride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Finasteride  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Finasteride No text entered.

Baseline Measures
    Finasteride  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 10.4  
Gender  
[units: participants]
 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
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1.  Primary:   Change in Visual Acuity at Month 3 Compared to Baseline.   [ Time Frame: 3 months ]

2.  Secondary:   Change in Visual Acuity at Month 6 Compared to Baseline   [ Time Frame: 6 months ]

3.  Secondary:   Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline   [ Time Frame: 3 months ]

4.  Secondary:   Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline   [ Time Frame: 6 months ]

5.  Secondary:   Change in Subretinal Fluid Volume at Month 3 Compared to Baseline   [ Time Frame: 3 Months ]

6.  Secondary:   Change in Subretinal Fluid Volume at Month 6 Compared to Baseline   [ Time Frame: 6 Months ]

7.  Secondary:   Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline   [ Time Frame: 3 Months ]

8.  Secondary:   Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline   [ Time Frame: 6 Months ]

9.  Secondary:   Change in Serum Testosterone Level at Month 3 Compared to Baseline   [ Time Frame: 3 Months ]

10.  Secondary:   Change in Serum Testosterone Level at Month 6 Compared to Baseline   [ Time Frame: 6 Months ]

11.  Secondary:   Change in Urinary Cortisol Level at Month 3 Compared to Baseline   [ Time Frame: 3 Months ]

12.  Secondary:   Change in Urinary Cortisol Level at Month 6 Compared to Baseline   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Catherine M. Meyerle, MD
Organization: National Eye Institute
phone: 301-435-7821
e-mail: meyerlec@nei.nih.gov


Publications:

Responsible Party: Catherine Meyerle, MD/National Eye Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00837252     History of Changes
Other Study ID Numbers: 090075, 09-EI-0075
Study First Received: February 4, 2009
Results First Received: April 21, 2011
Last Updated: May 23, 2011
Health Authority: United States: Food and Drug Administration