Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral GA Associated With AMD (SIRGA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier:
NCT00766649
First received: October 3, 2008
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: April 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Age-Related Macular Degeneration
Intervention: Drug: Sirolimus

  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
Sirolimus Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.

Participant Flow:   Overall Study
    Sirolimus  
STARTED     11  
COMPLETED     1  
NOT COMPLETED     10  



  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
Sirolimus Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.

Baseline Measures
    Sirolimus  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     11  
Age  
[units: years]
Mean ± Standard Deviation
  78.4  ± 7.1  
Gender  
[units: participants]
 
Female     6  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     11  



  Outcome Measures
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1.  Primary:   Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

2.  Primary:   Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

3.  Secondary:   Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months   [ Time Frame: Baseline and Month 24 ]

4.  Secondary:   Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

5.  Secondary:   Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

6.  Secondary:   Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline to Month 24 ]

7.  Secondary:   Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

8.  Secondary:   Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

9.  Secondary:   Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]

10.  Secondary:   Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline   [ Time Frame: Baseline and Month 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Wai T. Wong
Organization: National Eye Institute
phone: (301) 905-7301
e-mail: wongw@nei.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00766649     History of Changes
Other Study ID Numbers: 090008, 09-EI-0008
Study First Received: October 3, 2008
Results First Received: April 15, 2013
Last Updated: April 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration