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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Bevacizumab; Drug: dexamethasone intravitreal implant

• Registration Number: NCT01309451
• Lead Sponsor: Maturi, Raj K., M.D., P.C.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2013-11-05
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Results First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined group	dexamethasone intravitreal implant	Bevacizumab plus Ozurdex
Combined group	Bevacizumab	Bevacizumab plus Ozurdex
Bevacizumab alone	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline	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.
OCT CST	change in OCT CST from baseline to twelve months	change in optical coherence tomography central subfield thickness

Trial Locations

Locations (1)

Raj K. Maturi, MD; 🇺🇸 Indianapolis, Indiana, United States