Phase 4
Completed N=307
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT01427751 ↗Enrolled (actual)
307
Serious AEs
9.2%
Results posted
Feb 2016
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) — 56.6; 59.2; 7.9; 16.9 letters
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).
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 | — |
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
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. Informational only — not medical advice.