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Trial record 2 of 7 for:    15078674 [PUBMED-IDS]

A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT01120899
Recruitment Status : Completed
First Posted : May 11, 2010
Results First Posted : September 6, 2012
Last Update Posted : October 17, 2014
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
Catherine Cukras, M.D., National Institutes of Health Clinical Center (CC)

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

  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
Minocycline Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.

Participant Flow:   Overall Study
    Minocycline
STARTED   6 
Month 6   5 
Month 12   3 
Month 18   3 
COMPLETED   3 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  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
Minocycline Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.

Baseline Measures
   Minocycline 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.8  (9.5) 
Gender 
[Units: Participants]
 
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures

1.  Primary:   Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline   [ Time Frame: 6 months ]

2.  Secondary:   Change in BCVA in the Study Eye at 6 Months Compared to Baseline   [ Time Frame: Baseline and 6 Months ]

3.  Secondary:   Change in BCVA in the Study Eye at 12 Months Compared to Baseline   [ Time Frame: Baseline and 12 Months ]

4.  Secondary:   Change in BCVA in the Study Eye at 18 Months Compared to Baseline   [ Time Frame: Baseline and 18 Months ]

5.  Secondary:   Change in BCVA in the Study Eye at 24 Months Compared to Baseline   [ Time Frame: Baseline and 24 Months ]

6.  Secondary:   Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline   [ Time Frame: Baseline and 6 Months ]

7.  Secondary:   Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline   [ Time Frame: Baseline and 12 Months ]

8.  Secondary:   Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline   [ Time Frame: Baseline and 18 Months ]

9.  Secondary:   Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline   [ Time Frame: Baseline and 24 Months ]

10.  Secondary:   Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline   [ Time Frame: 6 Months ]

11.  Secondary:   Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline   [ Time Frame: 12 Months ]

12.  Secondary:   Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline   [ Time Frame: 18 Months ]

13.  Secondary:   Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline   [ Time Frame: 24 Months ]

14.  Secondary:   Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline   [ Time Frame: 6 Months ]

15.  Secondary:   Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline   [ Time Frame: 12 Months ]

16.  Secondary:   Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline   [ Time Frame: 18 Months ]

17.  Secondary:   Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline   [ Time Frame: 24 Months ]


  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 Cukras, MD, PhD, Principal Investigator, NEI
Organization: National Institutes of Health
phone: 301-435-5061
e-mail: cukrasc@nei.nih.gov


Publications of Results:
Other Publications:

Responsible Party: Catherine Cukras, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01120899     History of Changes
Other Study ID Numbers: 100098
10-EI-0098 ( Other Identifier: CNS IRB )
First Submitted: May 8, 2010
First Posted: May 11, 2010
Results First Submitted: August 2, 2012
Results First Posted: September 6, 2012
Last Update Posted: October 17, 2014