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

Phase 4

Completed

• Conditions: Retinal Vein Occlusion; Macular Edema
• Interventions: Drug: dexamethasone intravitreal implant; Biological: ranibizumab

• Registration Number: NCT01427751
• Lead Sponsor: Allergan

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Study Start: 2011-10-11
• Primary Completion: 2014-11-04
• Study Completion: 2014-11-04
• Results First Submitted: 2015-11-03
• Results First Submitted QC: 2016-01-19
• Results First Posted: 2016-02-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozurdex®	dexamethasone intravitreal implant	Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Lucentis®	ranibizumab	Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA)	Baseline, Month 12	BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)	Baseline, Month 12	Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.
Percentage of Patients With 15-or-More Letter Improvement in BCVA	Baseline, Month 12	BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Percentage of Patients With a 15-or-More Letter Decrease in BCVA	Baseline, Month 12	BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time to BCVA Improvement of 15-or-More Letters	12 Months	BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure	12 Months	Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)	Baseline, Month 12	The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.