Treatment of Non-infectious Intermediate and Posterior Uveitis Associated Macular Edema With Intravitreal Methotrexate (MEXX)

This study has been terminated.
(This study was terminated due to lack of recruitment.)
Sponsor:
Information provided by (Responsible Party):
Nida Sen, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01314417
First received: March 11, 2011
Last updated: October 17, 2013
Last verified: October 2013
Results First Received: July 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-infectious Intermediate and Posterior Uveitis
Intervention: Drug: Methotrexate

  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
Methotrexate Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.

Participant Flow:   Overall Study
    Methotrexate  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  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
Methotrexate Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.

Baseline Measures
    Methotrexate  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  55.0  ± 11.3  
Gender  
[units: participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.   [ Time Frame: 12 weeks ]

2.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 16 ]

6.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 20 ]

7.  Secondary:   Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 24 ]

8.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 4 ]

9.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 8 ]

10.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 16 ]

12.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 20 ]

13.  Secondary:   Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 24 ]

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

15.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 8 ]

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

17.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 16 ]

18.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:   Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks Compared to Baseline   [ Time Frame: Baseline and Week 20 ]

20.  Secondary:   Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline   [ Time Frame: Baseline and Week 12 ]

21.  Secondary:   Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:   Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline   [ Time Frame: Baseline and Week 12 ]

23.  Secondary:   Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline   [ Time Frame: Baseline and Week 24 ]

24.  Secondary:   Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period   [ Time Frame: Baseline and Week 74 ]

25.  Secondary:   Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period   [ Time Frame: Baseline and Week 74 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

26.  Secondary:   Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels   [ Time Frame: Baseline and Week 74 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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


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.  


Results Point of Contact:  
Name/Title: H. Nida Sen, MD, MHSc, Principal Investigator, NEI
Organization: National Institutes of Health
phone: 301-402-3254
e-mail: senh@nei.nih.gov


Publications:

Responsible Party: Nida Sen, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01314417     History of Changes
Other Study ID Numbers: 110107, 11-EI-0107
Study First Received: March 11, 2011
Results First Received: July 18, 2013
Last Updated: October 17, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration