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

Maturi, Raj K., M.D., P.C.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

BevacizumabDRUG

intravitreal, 1.25mg., monthly

dexamethasone intravitreal implantDRUG

0.7mg, intravitreal every 4 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Raj K. Maturi, MD

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline to 12 month

OCT CST

change in optical coherence tomography central subfield thickness

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.