Phase 3
Completed N=455
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT01599650 ↗Enrolled (actual)
455
Serious AEs
16.9%
Results posted
Nov 2016
Primary outcomePrimary: 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) — 59.5; 56.6; 56.8; 74.3 letters — p=<0.0001
◆ Published Evidence
Highly cited
119citations · ~13 / year
Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study.
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.
Linked Publications (3)
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Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study.
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Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER.
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SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
59.5; 56.6; 56.8; 74.3; 71.4; 62.8 | <0.0001 sig |
| SECONDARY The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline |
59.5; 56.6; 56.8; 74.5; 72.0; 65.9 | — |
| SECONDARY Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group |
11.4; 11.3 | — |
| SECONDARY Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 |
59.5; 56.6; 56.8; 72.7; 69.7; 61.7 | — |
| SECONDARY The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 |
59.5; 56.6; 56.8; 74.9; 72.3; 66.8 | — |
| SECONDARY 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 |
93.3; 96.1; 63.3; 89.4; 93.8; 77.8 | — |
| SECONDARY 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 |
168; 171; 57; 155; 157; 45 | — |
| SECONDARY 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 |
161; 167; 70; 150; 159; 63 | — |
| SECONDARY The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm |
-215.9; -242.5; -203.9; -228.1; -261.7; -232.7 | — |
| SECONDARY 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 |
5.6; 4.2; 3.7; 8.0; 5.0; 4.9 | — |
| SECONDARY BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm |
61.7; 68.16; 6.49 | — |
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
- Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
Data sourced from ClinicalTrials.gov (NCT01599650) and the linked publication. 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.