Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
1 other identifier
interventional
40
1 country
1
Brief Summary
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
October 29, 2014
CompletedOctober 29, 2014
October 1, 2014
2.1 years
March 3, 2011
November 5, 2013
October 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
baseline to 12 month
OCT CST
change in optical coherence tomography central subfield thickness
change in OCT CST from baseline to twelve months
Study Arms (2)
Bevacizumab alone
ACTIVE COMPARATORCombined group
ACTIVE COMPARATORBevacizumab plus Ozurdex
Interventions
0.7mg, intravitreal every 4 months
Eligibility Criteria
You may qualify if:
- Male or female age 18 years or older
- Type 1 or type 2 diabetes
- BCVA score of \>24 and \<78 letters
- Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) \>250microns
You may not qualify if:
- Anti-VEGF intravitreal treatment in last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks
- PRP or Focal laser in last 4 months
- Active iris neovascularization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raj K. Maturi, MD
Indianapolis, Indiana, 46290, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Raj K. Maturi, MD
- Organization
- Raj K. Maturi, MD, PC
Study Officials
- PRINCIPAL INVESTIGATOR
Raj K Maturi, MD
Midwest Eye Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 7, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 29, 2014
Results First Posted
October 29, 2014
Record last verified: 2014-10