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Trial record 3 of 6 for:    15078674 [PUBMED-IDS]

Sirolimus to Treat Diabetic Macular Edema (SDME)

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ClinicalTrials.gov Identifier: NCT00711490
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : June 3, 2011
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Retinopathy
Intervention: Drug: Sirolimus

  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 This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.

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



  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 This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.

Baseline Measures
   Sirolimus 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.2  (4.76) 
Gender 
[Units: Participants]
 
Female   3 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Change in Visual Acuity From Baseline to 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Change in Visual Acuity From Baseline to 12 Months   [ Time Frame: 12 months ]

3.  Secondary:   Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)   [ Time Frame: 6 months ]

4.  Secondary:   Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)   [ Time Frame: 12 months ]

5.  Secondary:   Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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

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


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


Publications of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00711490     History of Changes
Other Study ID Numbers: 080175
08-EI-0175
First Submitted: July 8, 2008
First Posted: July 9, 2008
Results First Submitted: May 10, 2011
Results First Posted: June 3, 2011
Last Update Posted: September 26, 2016