A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Overview
- Phase
- Phase 3
- Intervention
- Ranibizumab
- Conditions
- Branch Retinal Vein Occlusion
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 455
- Locations
- 1
- Primary Endpoint
- Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained before any study assessment is performed
- •Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- •BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Exclusion Criteria
- •Pregnant or nursing (lactating) women
- •Stroke or myocardial infarction less than 3 months before Screening
- •Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline.
- •Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- •Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- •Neovascularization of the iris or neovascular glaucoma in the study eye
- •Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- •Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
- •Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
- •Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
Arms & Interventions
1-ranibizumab monotherapy
Ranibizumab 0.5 mg
Intervention: Ranibizumab
2-ranibizumab with laser
Ranibizumab 0.5 mg + laser
Intervention: Ranibizumab
2-ranibizumab with laser
Ranibizumab 0.5 mg + laser
Intervention: Laser
3-laser monotherapy
Laser monotherapy with Ranibizumab 0.5 mg from Month 6
Intervention: Laser
Outcomes
Primary Outcomes
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)
Time Frame: Baseline, 6 Months
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
Secondary Outcomes
- Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6(From Baseline through Month 6)
- Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group(Day 1 through Month 23)
- The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline(Baseline, 24 Months)
- The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit(Baseline, Month 6 and Month 24)
- Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye(Month 6)
- The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24(Baseline, Month 12 and Month 24)
- The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline(Months 6 and 24)
- BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm(Month 24)
- Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye(Month 24)
- The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm(Month 12 and Month 24)