NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01331005
First received: April 6, 2011
Last updated: August 25, 2016
Last verified: August 2016
Results First Received: December 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: nepafenac 0.1% drops
Other: Nepafenac Vehicle

  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
Placebo

Placebo will be given three times per day for one year

Nepafenac Vehicle: Placebo

Nepafenac 0.1% Drops

Nepafenac drops will be given three times per day for one year

nepafenac 0.1% drops: One drop three times per day for one year


Participant Flow:   Overall Study
    Placebo     Nepafenac 0.1% Drops  
STARTED     64     61  
COMPLETED     60     57  
NOT COMPLETED     4     4  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 2                 3  



  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.
No text entered.

Reporting Groups
  Description
Placebo

Placebo will be given three times per day for one year

Nepafenac Vehicle: Placebo

Nepafenac 0.1% Drops

Nepafenac drops will be given three times per day for one year

nepafenac 0.1% drops: One drop three times per day for one year

Total Total of all reporting groups

Baseline Measures
    Placebo     Nepafenac 0.1% Drops     Total  
Number of Participants  
[units: participants]
  64     61     125  
Age, Customized  
[units: years]
Median (Inter-Quartile Range)
  59  
  (51 to 66)  
  60  
  (52 to 68)  
  60  
  (51 to 67)  
Gender  
[units: participants]
     
Female     28     23     51  
Male     36     38     74  
Race/Ethnicity, Customized  
[units: participants]
     
White     38     44     82  
African American     13     7     20  
Hispanic or Latino     12     5     17  
American Indian/Alaskan Native     1     0     1  
Native Hawaiian/Other Pacific Islander     0     2     2  
Asian     0     2     2  
More than one race     0     1     1  
Type of Diabetes  
[units: participants]
     
Type 1     5     5     10  
Type 2     56     53     109  
Uncertain     3     3     6  
Duration of Diabetes  
[units: years]
Mean (Standard Deviation)
  17  (11)     19  (11)     18  (11)  
Hemoglobin A1c  
[units: Percent HbA1c]
Median (Inter-Quartile Range)
  7.9  
  (7.2 to 10)  
  8.1  
  (7.1 to 8.7)  
  7.9  
  (7.1 to 9.0)  
Electronic-Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score [1]
[units: units on a scale]
Mean (Standard Deviation)
  83  (7)     82  (6)     83  (7)  
History of Diabetic Macular Edema Treatment  
[units: participants]
     
yes     28     30     58  
no     36     31     67  
History of Panretinal Photocoagulation  
[units: participants]
     
yes     11     13     24  
no     53     48     101  
Optical Coherence Tomography Machine  
[units: participants]
     
Zeiss Cirrus     41     37     78  
Heidelberg Spectralis     23     24     47  
Optical Coherence Tomography Central Subfield Thickness  
[units: Microns]
Mean (Standard Deviation)
  218  (25)     227  (29)     223  (27)  
Optical Coherence Tomography Retinal Volume  
[units: mm^3]
Mean (Standard Deviation)
  7.7  (0.4)     7.9  (0.6)     7.8  (0.5)  
[1] Visual acuity was measured with the E-ETDRS method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.



  Outcome Measures

1.  Primary:   Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3   [ Time Frame: From Baseline to 12 months ]

2.  Secondary:   Corneal Ulceration   [ Time Frame: Baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Corneal Melting   [ Time Frame: Baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Irritation   [ Time Frame: Baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Mean Change in Visual Acuity   [ Time Frame: baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in OCT Central Subfield Thickness   [ Time Frame: baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Change in Number of Thickened Subfields on OCT   [ Time Frame: Baseline to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change in Level of Diabetic Retinopathy on Stereoscopic Fundus Photographs   [ Time Frame: Baseline to 12 months ]
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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Adam Glassman
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: drcrnet@jaeb.org


Publications of Results:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01331005     History of Changes
Other Study ID Numbers: DRCR.net Protocol R
U10EY018817-03 ( US NIH Grant/Contract Award Number )
U10EY014231-09 ( US NIH Grant/Contract Award Number )
Study First Received: April 6, 2011
Results First Received: December 30, 2014
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration