Phase 4 N=30 Randomized Single-blind Treatment

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

Retinal Vein Occlusions

Bottom Line

View on ClinicalTrials.gov: NCT01085734 ↗

Enrolled (actual)

Serious AEs

23.3%

Results posted

Apr 2014

Primary outcome: Primary: Change From Baseline Visual Acuity at 6 Months — 2.3; 0.1 ETDRS score

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Avastin (Drug); Osurdex (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Maturi, Raj K., M.D., P.C.
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Visual Acuity at 6 Months	2.3; 0.1	—
SECONDARY Number of Injections Needed	14; 11	—
SECONDARY Change in Macular Thickness and Macular Volume	45.4; -55.6	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01085734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.