Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01309451
First received: March 3, 2011
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: November 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: Bevacizumab
Drug: dexamethasone intravitreal implant

  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
The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.

Reporting Groups
  Description
Bevacizumab Alone monthly injection of bevacizumab intravitreally when retreatment criteria met
Combined Group bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.

Participant Flow:   Overall Study
    Bevacizumab Alone     Combined Group  
STARTED     19 [1]   21 [1]
COMPLETED     17 [1]   18 [1]
NOT COMPLETED     2     3  
[1] unit of measure is number of eyes



  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.
The unit of "eyes" is used to described the number of participants since some subjects had both eyes in the study and it is not feasible to separate those into their own group.

Reporting Groups
  Description
Bevacizumab Alone Bevacizumab only
Combine Group Bevacizumab plus Ozurdex
Total Total of all reporting groups

Baseline Measures
    Bevacizumab Alone     Combine Group     Total  
Number of Participants  
[units: participants]
  19     21     40  
Age  
[units: eyes]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     5     10  
>=65 years     14     16     30  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 9     59  ± 12     60.5  ± 10  
Gender  
[units: eyes]
     
Female     9     10     19  
Male     10     11     21  
Region of Enrollment [1]
[units: eyes]
     
United States     19     21     40  
[1] The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline   [ Time Frame: baseline to 12 month ]

2.  Primary:   OCT CST   [ Time Frame: change in OCT CST from baseline to twelve months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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: Raj K. Maturi, MD
Organization: Raj K. Maturi, MD, PC
phone: 317-817-1414
e-mail: rmaturi@gmail.com


No publications provided


Responsible Party: Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01309451     History of Changes
Other Study ID Numbers: OA002
Study First Received: March 3, 2011
Results First Received: November 5, 2013
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration