- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309451
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
October 28, 2014 updated by: Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46290
- Raj K. Maturi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Bevacizumab alone
|
intravitreal, 1.25mg., monthly
Other Names:
|
ACTIVE_COMPARATOR: Combined group
Bevacizumab plus Ozurdex
|
intravitreal, 1.25mg., monthly
Other Names:
0.7mg, intravitreal every 4 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: change in OCT CST from baseline to twelve months
|
change in optical coherence tomography central subfield thickness
|
change in OCT CST from baseline to twelve months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raj K Maturi, MD, Midwest Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
March 3, 2011
First Submitted That Met QC Criteria
March 4, 2011
First Posted (ESTIMATE)
March 7, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 29, 2014
Last Update Submitted That Met QC Criteria
October 28, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Bevacizumab
Other Study ID Numbers
- OA002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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