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OpenTrials
Completed

NCT Number: NCT01309451

Ozurdex as Adjunct to Avastin Compared to Avastin Alone in 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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Raj K. Maturi, MD

Indianapolis, Indiana, 46290, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

intravitreal, 1.25mg., monthly

Other names: Avastin

dexamethasone Intravitreal Implant

Drug

0.7mg, intravitreal every 4 months

Other names: Ozurdex

Primary outcomes

  1. 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.

  2. OCT CST

    Time frame: change in OCT CST from baseline to twelve months

    change in optical coherence tomography central subfield thickness

Sponsors and collaborators

Lead sponsor

Maturi, Raj K., M.D., P.C.

Indiv

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2011
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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