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

Phase 4

Completed

• Conditions: Retinal Vein Occlusions
• Interventions: Drug: Avastin; Drug: Osurdex

• Registration Number: NCT01085734
• Lead Sponsor: Maturi, Raj K., M.D., P.C.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-04-24
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Avastin	Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
Group 2	Osurdex	Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Group 2	Avastin	Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema

Primary Outcome Measures

Name	Time	Method
Change From Baseline Visual Acuity at 6 Months	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 Outcome Measures

Name	Time	Method
Number of Injections Needed	baseline to 6 months	number of Avastin and Ozurdex injections needed
Change in Macular Thickness and Macular Volume	6 months	OCT central subfield thickness measured in microns

Trial Locations

Locations (1)

Raj K. Maturi, MD; 🇺🇸 Indianapolis, Indiana, United States