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

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

Official Title
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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

Conditions
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Retinal Vein Occlusions

Intervention / Treatment
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* Drug: Avastin
* Drug: Osurdex
* Drug: Avastin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema | Drug: Avastin<br>* 1.25mg intravitreally<br>|
| Active Comparator: Group 2<br>Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema | Drug: Osurdex<br>* 0.7mg intravitreally<br>Drug: Avastin<br>* 1.25mg intravitreally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Visual Acuity at 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Injections Needed | number of Avastin and Ozurdex injections needed | baseline to 6 months | 
| Change in Macular Thickness and Macular Volume | OCT central subfield thickness measured in microns | 6 months |