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Trial record 3 of 7 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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sirolimus
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Sirolimus
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  20.0%
>=65 years
4
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
67.2  (4.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Change in Visual Acuity From Baseline to 6 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Eye Fellow Eye
Hide Arm/Group Description:
The study eye was treated with sirolimus.
The fellow eye was not treated with sirolimus.
Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: ETDRS letters
7
(-7 to 13)
0
(-4 to 2)
2.Secondary Outcome
Title Change in Visual Acuity From Baseline to 12 Months
Hide 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 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Eye Fellow Eye
Hide Arm/Group Description:
The study eye was treated with sirolimus.
The fellow eye was not treated with sirolimus.
Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: ETDRS letters
1
(-8 to 13)
-1
(-3 to 1)
3.Secondary Outcome
Title Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)
Hide Description Retinal 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Eye Fellow Eye
Hide Arm/Group Description:
The study eye was treated with sirolimus.
The fellow eye was not treated with sirolimus.
Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: μm
-37
(-163 to 74)
-10
(-63 to 0)
4.Secondary Outcome
Title Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)
Hide Description Retinal 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 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Eye Fellow Eye
Hide Arm/Group Description:
The study eye was treated with sirolimus.
The fellow eye was not treated with sirolimus.
Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: μm
-55
(-321 to 144)
-51
(-152 to -7)
5.Secondary Outcome
Title Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame Duration of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sirolimus
Hide Arm/Group Description 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.
All-Cause Mortality
Sirolimus
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sirolimus
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sirolimus
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  2/5 (40.00%)  3
Eye disorders   
Vision blurred  1  1/5 (20.00%)  1
Visual acuity reduced  1  1/5 (20.00%)  1
Conjunctival haemorrhage  1  1/5 (20.00%)  1
Conjunctival hyperaemia  1  1/5 (20.00%)  1
General disorders   
Oedema peripheral  1  4/5 (80.00%)  5
Infections and infestations   
Sinusitis  1  1/5 (20.00%)  1
Injury, poisoning and procedural complications   
Rib fracture  1  1/5 (20.00%)  1
Investigations   
Blood urea increased  1  2/5 (40.00%)  2
White blood cell count decreased  1  1/5 (20.00%)  1
Blood cholesterol increased  1  2/5 (40.00%)  2
Blood glucose increased  1  2/5 (40.00%)  2
Blood uric acid increased  1  2/5 (40.00%)  2
Glycosylated haemoglobin increased  1  1/5 (20.00%)  1
Red cell distribution width increased  1  1/5 (20.00%)  1
Blood creatine phosphokinase increased  1  1/5 (20.00%)  1
Haematocrit decreased  1  1/5 (20.00%)  1
White blood cell count increased  1  1/5 (20.00%)  1
Protein urine present  1  1/5 (20.00%)  1
Intraocular pressure increased  1  1/5 (20.00%)  4
Blood trigylcerides increased  1  2/5 (40.00%)  2
Blood creatinine increased  1  2/5 (40.00%)  2
Red blood cell count decreased  1  1/5 (20.00%)  1
Blood potassium increased  1  1/5 (20.00%)  2
Blood pressure increased  1  1/5 (20.00%)  2
Haemoglobin decreased  1  1/5 (20.00%)  1
Blood chloride increased  1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  3/5 (60.00%)  4
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/5 (20.00%)  1
Arthralgia  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Ecchymosis  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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
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