Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)

Phase 3

Completed

Conditions: Visual Impairment
Macular Edema
Branch Retinal Vein Occlusion

Interventions: Other: Dexamethasone Implant
Drug: Ranibizumab
Other: Sham injection

Registration Number: NCT01396057

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 244

Inclusion Criteria

Patients diagnosed with visual impairment due to macular edema following BRVO
Diagnosis of BRVO at maximum 6 months prior to Screening
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Central retinal thickness (CRT) < 250 µm in the study eye
Prior episode of RVO in the study eye
Active formation of new vessels in the study eye
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Sham injection	Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Dexamethasone	Dexamethasone Implant	Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Ranibizumab	Ranibizumab	Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

Primary Outcome Measures

Name	Time	Method
Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline	Baseline, month 6	the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6

Secondary Outcome Measures

Name	Time	Method
Rate of the Internal Ocular Pressure (IOP)	Baseline, month 6	The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment	Baseline, 6 month	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Time to Achieve a Significant Improvement ≥ 15 Letters	Baseline, month 6	The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Change Over Time in BCVA	baseline, month 6	The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires	Baseline, month 6	The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.
Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6	Baseline, month 6	The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Change Over Time of the Central Retinal Thickness (CRT)	Baseline, month 6	Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires	Baseline, month 6	SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires	Baseline, month 6	The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.