Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies

This study has been terminated.
(recent research indicates Lucentis to be an effictive treatment)
Sponsor:
Information provided by (Responsible Party):
Shree Kurup, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00779142
First received: October 22, 2008
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Intervention: Drug: Methotrexate intravenous 25mg/ml

  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
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
Methotrexate 25mg/ml

Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.


Participant Flow:   Overall Study
    Methotrexate 25mg/ml  
STARTED     5 [1]
COMPLETED     2 [2]
NOT COMPLETED     3  
Screen Failures                 3  
[1] 5 patients signed consent and were screened.
[2] Only 2 patients were actually enrolled.



  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.
Patients with Recalcitrant Diabetic Macular Edema

Reporting Groups
  Description
Methotrexate 25mg/ml Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Baseline Measures
    Methotrexate 25mg/ml  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Mean ± Standard Deviation
  50.8  ± 19.05781  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     1  
Gender  
[units: participants]
 
Female     4  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures

1.  Primary:   Primary Would be 30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection   [ Time Frame: 4 weeks ]

2.  Secondary:   Secondary Would be Increase in Visual Acutiy (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection.   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting 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: Dr. Shree Kurup
Organization: Wake Forest Baptist Health Eye Center
phone: 336-716-4091
e-mail: skurup@wakehealth.edu


Publications:

Responsible Party: Shree Kurup, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00779142     History of Changes
Other Study ID Numbers: 5865 Methotrexate
Study First Received: October 22, 2008
Results First Received: May 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration