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
Overview
- Phase
- Phase 4
- Intervention
- Avastin
- Conditions
- Retinal Vein Occlusions
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change From Baseline Visual Acuity at 6 Months
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Raj K. Maturi, MD
President
Maturi, Raj K., M.D., P.C.
Eligibility Criteria
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
Arms & Interventions
Group 1
Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
Intervention: Avastin
Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Intervention: Osurdex
Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Intervention: Avastin
Outcomes
Primary Outcomes
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
- Number of Injections Needed(baseline to 6 months)
- Change in Macular Thickness and Macular Volume(6 months)