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Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01599650•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (82)

Novartis Investigative Site

Parramatta, New South Wales, Australia

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Victoria, British Columbia, Canada

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Boisbriand, Quebec, Canada

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

November 10, 2016

Enrollment

455

ACTUAL participants

Conditions

Branch Retinal Vein Occlusion

Interventions

Ranibizumab

DRUG

Laser

PROCEDURE

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

NCT05476926

Neovascular Age-related Macular DegenerationDiabetic Macular Edema+4 more

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COMPLETEDPHASE3

A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss

NCT05520177

Branch Retinal Vein Occlusion

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss

Ocular Safety and Usability Study for FYB203 PFS

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO

Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety