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Completed

NCT Number: NCT01085734

Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

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Key information

Conditions

Retinal Vein Occlusions Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

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: Yes

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

Inclusion criteria

  • male or female age 18 years or older
  • Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
  • Best correct visual acuity of greater than 24 and less than 80
  • Presence of macular edema defined as OCT central subfield thickness of >250

Exclusion criteria

  • intravitreal anti-VEGF treatment in study eye within six weeks of baseline
  • intravitreal steroid treatment in the study eye within eight weeks of baseline visit
  • PRP in the study eye within 4 month of baseline visit
  • Active iris neovascularization in study eye
  • Uncontrolled systemic disease
  • Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications

Treatment and study plan

Avastin

Drug

1.25mg intravitreally

Osurdex

Drug

0.7mg intravitreally

Primary outcomes

  1. Change From Baseline Visual Acuity at 6 Months

    Time frame: 6 months

    Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

Secondary outcomes

  1. Number of Injections Needed

    Time frame: baseline to 6 months

    number of Avastin and Ozurdex injections needed

  2. Change in Macular Thickness and Macular Volume

    Time frame: 6 months

    OCT central subfield thickness measured in microns

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Official study title

A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 12, 2010
Registry last updated
Apr 21, 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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