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

Study Overview
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Brief Summary
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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).

Conditions
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Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
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* Drug: dexamethasone intravitreal implant
* Biological: ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozurdex®<br>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. | Drug: dexamethasone intravitreal implant<br>* 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.<br>* Other names: Ozurdex®;|
| Active Comparator: Lucentis®<br>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. | Biological: ranibizumab<br>* 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.<br>* Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | 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. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | 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. | Baseline, Month 12 | 
| Percentage of Patients With 15-or-More Letter Improvement in BCVA | 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. | Baseline, Month 12 | 
| Percentage of Patients With a 15-or-More Letter Decrease in BCVA | 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). | Baseline, Month 12 | 
| Time to BCVA Improvement of 15-or-More Letters | 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. | 12 Months | 
| Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | 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. | Baseline, Month 12 | 
| Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure | 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. | 12 Months |