Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eye

A 24-month, phase IIIb, open-label, randomized, activecontrolled, 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 (BRVO) - BRIGHTER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002859-34-IE

Enrollment

450

Registered

2011-11-03

Start date

2012-04-20

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

visual impairment due to macular edema secondary to branch retinal occlusion (BRVO) MedDRA version: 14.0 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.0 Level: PT Classification code 10038907 Term: Retinal vein occlusion System Organ Class: 10015919 - Eye disorders MedDRA version: 14.0 Level: PT Classification code 10047571 Term: Visual impairment System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: LUCENTIS Product Name: LUCENTIS Product Code: RFB002E Pharmaceutical Form: Solution for injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Current Sponsor code: RFB002 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent must be obtained before any study assessment is performed • Male or female patients =18 years of age • Diagnosis of visual impairment exclusively due to ME secondary to BRVO • BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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. Antihypertensive treatment can be initiated and must be taken for at least 30 days after which the patient can be assessed for study eligibility a second time • Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye • Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg while on medication or according to investigator’s judgment) 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 (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®]) • Treatment (or anticipated treatment in the fellow eye for non-RVO indications during the study) with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months before Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab [Avastin®]) • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate that an individualized stabilization-criteria-driven PRN dosing regimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive laser treatment has superior efficacy as compared to the current standard of care, laser photocoagulation, in patients with visual impairment due to ME secondary to BRVO. The primary objective will be assessed by the mean BCVA change at Month 6 compared to Baseline.;Secondary Objective: To demonstrate in a first step that treatment with ranibizumab with adjunctive laser is noninferior to treatment with ranibizumab monotherapy as assessed by the mean average BCVA change from Month 1 through Month 24 compared to Baseline. To demonstrate in a second step (after demonstrating non-inferiority) that ranibizumab with adjunctive laser reduces the number of ranibizumab retreatments as compared to ranibizumab monotherapy by assessing the number of ranibizumab treatments applied up to Month 23.;Primary end point(s): The primary variable is the mean BCVA change at Month 6 compared to Baseline in patients with visual impairment due to ME secondary to BRVO.;Timepoint(s) of evaluation of this end point: at Month 6	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate that an individualized stabilization-criteria-driven PRN dosing regimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive laser treatment has superior efficacy as compared to the current standard of care, laser photocoagulation, in patients with visual impairment due to ME secondary to BRVO. The primary objective will be assessed by the mean BCVA change at Month 6 compared to Baseline.;Secondary Objective: To demonstrate in a first step that treatment with ranibizumab with adjunctive laser is noninferior to treatment with ranibizumab monotherapy as assessed by the mean average BCVA change from Month 1 through Month 24 compared to Baseline. To demonstrate in a second step (after demonstrating non-inferiority) that ranibizumab with adjunctive laser reduces the number of ranibizumab retreatments as compared to ranibizumab monotherapy by assessing the number of ranibizumab treatments applied up to Month 23.;Primary end point(s): The primary variable is the mean BCVA change at Month 6 compared to Baseline in patients with visual impairment due to ME secondary to BRVO.;Timepoint(s) of evaluation of this end point: at Month 6

—

Secondary

Measure	Time frame
Secondary end point(s): • The mean average change in BCVA from Month 1 through Month 24 compared to Baseline • The number of ranibizumab treatments • The mean average change in BCVA from Month 1 through Month 6 compared to Baseline • The mean change in BCVA from Baseline up to Month 12 and Month 24, by visit • The mean average change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) for all following visits until End of Study • The mean change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) assessed on a monthly basis until End of Study • The number and proportion of patients with a BCVA gain of =1, =5, =10, =15, and =30 letters / loss of <15 letters from Baseline up to Month 6 and Month 24, by visit • The number and proportion of patients with a BCVA value =73 letters (20/40 Snellen equivalent) from Baseline up to Month 6 and Month 24, by visit • The mean average BCVA change from the time point of first ranibizumab treatment for all following visits until End of Study in patients randomized to laser • The mean change in CRC-assessed CSFT from Baseline up to Month 6 and Month 24, by visit • 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;Timepoint(s) of evaluation of this end point: From Month 1 through Month 24	—

Measure

Time frame

Secondary end point(s): • The mean average change in BCVA from Month 1 through Month 24 compared to Baseline • The number of ranibizumab treatments • The mean average change in BCVA from Month 1 through Month 6 compared to Baseline • The mean change in BCVA from Baseline up to Month 12 and Month 24, by visit • The mean average change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) for all following visits until End of Study • The mean change in BCVA from the time point of the first treatment interruption (due to BCVA stabilization) assessed on a monthly basis until End of Study • The number and proportion of patients with a BCVA gain of =1, =5, =10, =15, and =30 letters / loss of <15 letters from Baseline up to Month 6 and Month 24, by visit • The number and proportion of patients with a BCVA value =73 letters (20/40 Snellen equivalent) from Baseline up to Month 6 and Month 24, by visit • The mean average BCVA change from the time point of first ranibizumab treatment for all following visits until End of Study in patients randomized to laser • The mean change in CRC-assessed CSFT from Baseline up to Month 6 and Month 24, by visit • 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;Timepoint(s) of evaluation of this end point: From Month 1 through Month 24

—

Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

Public ContactCollette Cairnduff

Novartis

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026