Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion (BRIGHTER)

Novartis

Status and phase: Completed; Phase 3

Conditions: Branch Retinal Vein Occlusion

Treatments: Drug: Ranibizumab; Procedure: Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599650

CRFB002E2402

2011-002859-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 455 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

455 participants in 3 patient groups

1-ranibizumab monotherapy

Experimental group

Description:

Ranibizumab 0.5 mg

Treatment:

Drug: Ranibizumab

2-ranibizumab with laser

Experimental group

Description:

Ranibizumab 0.5 mg + laser

Treatment:

Procedure: Laser

Drug: Ranibizumab

3-laser monotherapy

Active Comparator group

Description:

Laser monotherapy with Ranibizumab 0.5 mg from Month 6

Treatment:

Procedure: Laser