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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Maturi, Raj K., M.D., P.C.
Study ID
NCT01309451
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    intravitreal, 1.25mg., monthly
  • dexamethasone intravitreal implant — DRUG
    0.7mg, intravitreal every 4 months

Study Details

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.

Key Dates

First listed
Mar 7, 2011
Start date
Mar 31, 2011
Status verified
Oct 2014
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab alone
  • Active Comparator: Combined group
    Bevacizumab plus Ozurdex

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Raj K. Maturi, MDIndianapolisIndiana46290-

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