Phase 4 N=307 Randomized Single-blind Treatment

Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

Retinal Vein Occlusion · Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT01427751 ↗

Enrolled (actual)

307

Serious AEs

9.2%

Results posted

Feb 2016

Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) — 56.6; 59.2; 7.9; 16.9 letters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: dexamethasone intravitreal implant (Drug); ranibizumab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA)	56.6; 59.2; 7.9; 16.9	—
SECONDARY Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)	553.2; 561.0; -219.2; -253.5	—
SECONDARY Percentage of Patients With 15-or-More Letter Improvement in BCVA	33.8; 59.5	—
SECONDARY Percentage of Patients With a 15-or-More Letter Decrease in BCVA	9.1; 0.7	—
SECONDARY Time to BCVA Improvement of 15-or-More Letters	73.7; 82.0	—
SECONDARY Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)	78.1; 80.7; 3.5; 6.6	—
SECONDARY Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure	4.5; 0.7	—

Summary

This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

Eligibility Criteria

Inclusion Criteria

Diagnosis of branch retinal vein occlusion in at least one eye
Visual acuity between 20/400 to 20/40

Exclusion Criteria

Active eye infection
Ocular hypertension which is not controlled on monotherapy (one medication)
Anticipated need for eye surgery during the study
Cataract surgery in either eye within 3 months
Eye surgery including laser of any type within 6 months
Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
Use of ocular steroids within 3 months
Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01427751). 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.