Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Raj K. Maturi, MD
Study ID
NCT02036424
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ozurdex — DRUG
    intravitreal steroid
  • Bevacizumab — DRUG
    antiVEGF

Study Details

To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

Key Dates

First listed
Jan 15, 2014
Start date
Jan 31, 2014
Status verified
Nov 2015
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Active Comparator: Bevacizumab
    1.25 mg intravitreal injection given monthly during a 6 month period
  • Active Comparator: Ozurdex
    Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections

Primary Outcome Measure

Mean Visual Acuity Change [ Time Frame: baseline to month 7 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Raj K Maturi MD PCIndianapolisIndiana46290-

Find similar trials in Indianapolis, IN

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Raj K Maturi MD PC· Indianapolis, IN

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