Sirolimus for Advanced Age-Related Macular Degeneration (SIRGA2)

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:
NCT01445548
First received: September 30, 2011
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: April 7, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Age-Related Macular Degeneration
Geographic Atrophy
Intervention: Drug: Sirolimus

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sirolimus

Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.

As of September 2012, sirolimus intravitreal injections were no longer administered to participants.


Participant Flow:   Overall Study
    Sirolimus  
STARTED     6  
COMPLETED     5  
NOT COMPLETED     1  
Adverse Event                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Sirolimus

Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.

As of September 2012, sirolimus intravitreal injections were no longer administered to participants.


Baseline Measures
    Sirolimus  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Mean ± Standard Deviation
  74.33  ± 8.45  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     5  
Gender  
[units: participants]
 
Female     2  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

2.  Primary:   Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

3.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline   [ Time Frame: Baseline and Month 12 ]

4.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline   [ Time Frame: Baseline and Month 12 ]

5.  Secondary:   Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

6.  Secondary:   Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

7.  Secondary:   Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

8.  Secondary:   Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

9.  Secondary:   Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

10.  Secondary:   Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

11.  Secondary:   Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

12.  Secondary:   Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

13.  Secondary:   Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

14.  Secondary:   Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

15.  Secondary:   Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

16.  Secondary:   Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

17.  Secondary:   Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

18.  Secondary:   Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.   [ Time Frame: Baseline and Month 12 ]

19.  Secondary:   Development of Exudative Age-Related Macular Degeneration (AMD) as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline   [ Time Frame: Baseline and 12 Months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wai T. Wong, MD, PhD
Organization: National Eye Institute
phone: 301-496-7566
e-mail: wongw@nei.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT01445548     History of Changes
Other Study ID Numbers: 110249, 11-EI-0249
Study First Received: September 30, 2011
Results First Received: April 7, 2014
Last Updated: May 15, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration