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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571232
First Posted: April 5, 2012
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Ron P. Gallemore, Retina Macula Institute
Results First Submitted: April 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetic Macular Edema
Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Interventions: Drug: dexamethasone intravitreal implant
Drug: intravitreal bevacizumab

  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
Ozurdex

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Avastin

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.


Participant Flow:   Overall Study
    Ozurdex   Avastin
STARTED   10   10 
COMPLETED   9   9 
NOT COMPLETED   1   1 
Lost to Follow-up                0                1 
Withdrawal by Subject                1                0 



  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
Ozurdex

Patients in this group receive Ozurdex at initial visit and at month 4

dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Avastin

Patients in this group receive Avastin Q1 month for 5 months.

intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Total Total of all reporting groups

Baseline Measures
   Ozurdex   Avastin   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (1.8)   61.2  (2.9)   62.6  (1.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      3  30.0%      8  40.0% 
Male      5  50.0%      7  70.0%      12  60.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Change in Visual Acuity (Number of ETDRS Letters).   [ Time Frame: 6 months ]

2.  Primary:   The Change in Central Foveal Thickness (Microns on High Resolution OCT).   [ Time Frame: 6 months ]

3.  Secondary:   The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.   [ Time Frame: 6 months ]

4.  Secondary:   The Change in Macular Leakage on Fluorescein Angiography From Baseline   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   The Change in Mean Macular Sensitivity on Microperimetry From Baseline   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 NOT 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.


Results Point of Contact:  
Name/Title: Ron P. Gallemore M.D., Ph.D.
Organization: Retina Macula Institute
phone: 310-944-9393
e-mail: rongallemoremd@gmail.com



Responsible Party: Ron P. Gallemore, Retina Macula Institute
ClinicalTrials.gov Identifier: NCT01571232     History of Changes
Other Study ID Numbers: IIT-406
First Submitted: April 2, 2012
First Posted: April 5, 2012
Results First Submitted: April 26, 2017
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017