--- title: Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion nct_id: NCT01599650 overall_status: COMPLETED phase: PHASE3 sponsor: Novartis Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Branch Retinal Vein Occlusion countries: Australia, Canada, Czechia, Denmark, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01599650.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01599650" ct_last_update_post_date: 2016-11-10 last_seen_at: "2026-05-12T06:51:39.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion **Official Title:** 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 **NCT ID:** [NCT01599650](https://clinicaltrials.gov/study/NCT01599650) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 455 - **Lead Sponsor:** Novartis Pharmaceuticals - **Conditions:** Branch Retinal Vein Occlusion - **Start Date:** 2012-05 - **Completion Date:** 2015-05 - **CT.gov Last Update:** 2016-11-10 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **1-ranibizumab monotherapy** (EXPERIMENTAL) — Ranibizumab 0.5 mg - **2-ranibizumab with laser** (EXPERIMENTAL) — Ranibizumab 0.5 mg + laser - **3-laser monotherapy** (ACTIVE_COMPARATOR) — Laser monotherapy with Ranibizumab 0.5 mg from Month 6 ## Interventions - **Ranibizumab** (DRUG) - **Laser** (PROCEDURE) — laser photocoagulation ## 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 - **The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline** _(time frame: Baseline, 24 Months)_ - **Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group** _(time frame: Day 1 through Month 23)_ - **Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6** _(time frame: From Baseline through Month 6)_ - **The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24** _(time frame: Baseline, Month 12 and Month 24)_ - **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** _(time frame: 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** _(time frame: Month 6)_ - **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** _(time frame: Month 24)_ - **The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm** _(time frame: 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** _(time frame: 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** _(time frame: Month 24)_ ## 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 - Novartis Investigative Site, Montreal, Quebec, Canada - Novartis Investigative Site, Olomouc, Czechia - Novartis Investigative Site, Prague, Czechia - Novartis Investigative Site, Glostrup Municipality, Denmark - Novartis Investigative Site, Dijon, France - Novartis Investigative Site, Lyon, France - Novartis Investigative Site, Nice, France - Novartis Investigative Site, Paris, France - Novartis Investigative Site, Paris, France - Novartis Investigative Site, Paris, France - Novartis Investigative Site, Pátrai, Greece, Greece - Novartis Investigative Site, Thessaloniki, Greece, Greece - Novartis Investigative Site, Athens, GR, Greece - Novartis Investigative Site, Heraklion Crete, GR, Greece - Novartis Investigative Site, Larissa, GR, Greece - Novartis Investigative Site, Thessaloniki, GR, Greece - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Debrecen, Hungary - Novartis Investigative Site, Dublin, Ireland, Ireland - Novartis Investigative Site, Dublin, Ireland - Novartis Investigative Site, Bologna, BO, Italy - Novartis Investigative Site, Florence, FI, Italy - Novartis Investigative Site, Milan, MI, Italy - Novartis Investigative Site, Milan, MI, Italy - Novartis Investigative Site, Roma, RM, Italy - Novartis Investigative Site, Torino, TO, Italy - Novartis Investigative Site, Bari, Italy - Novartis Investigative Site, Udine, Italy - Novartis Investigative Site, Leiden 2333 ZA, Netherlands, Netherlands - Novartis Investigative Site, Rotterdam, Netherlands - Novartis Investigative Site, Tilburg, Netherlands - Novartis Investigative Site, Bielsko-Biala, Poland - Novartis Investigative Site, Gdansk, Poland - Novartis Investigative Site, Krakow, Poland - Novartis Investigative Site, Lublin, Poland - Novartis Investigative Site, Warsaw, Poland - Novartis Investigative Site, Wroclaw, Poland - Novartis Investigative Site, Porto, Porto District, Portugal - Novartis Investigative Site, Coimbra, Portugal, Portugal - Novartis Investigative Site, Coimbra, Portugal, Portugal - Novartis Investigative Site, Porto, Portugal, Portugal - Novartis Investigative Site, Lisbon, Portugal - Novartis Investigative Site, Lisbon, Portugal - Novartis Investigative Site, Žilina, Slovak Republic, Slovakia - Novartis Investigative Site, Bratislava, Slovakia, Slovakia - Novartis Investigative Site, Banská Bystrica, Slovakia - Novartis Investigative Site, Bratislava, Slovakia - Novartis Investigative Site, Bilbao, Basque Country, Spain - Novartis Investigative Site, Valladolid, Castille and León, Spain - Novartis Investigative Site, Barcelona, Catalonia, Spain - Novartis Investigative Site, Barcelona, Catalonia, Spain - Novartis Investigative Site, L'Hospitalet de Llobregat, Catalonia, Spain - Novartis Investigative Site, Santiago de Compostela, Galicia, Spain - Novartis Investigative Site, Madrid, Madrid, Spain - Novartis Investigative Site, Alicante, Valencia, Spain - Novartis Investigative Site, Valencia, Valencia, Spain - Novartis Investigative Site, Valencia, Valencia, Spain - Novartis Investigative Site, Örebro, Sweden - Novartis Investigative Site, Olten, Switzerland, Switzerland - Novartis Investigative Site, Zurich, Switzerland, Switzerland - Novartis Investigative Site, Bern, Switzerland - Novartis Investigative Site, Lausanne, Switzerland - Novartis Investigative Site, Frimley, Surrey, United Kingdom - Novartis Investigative Site, London, United Kingdom, United Kingdom - Novartis Investigative Site, Belfast, United Kingdom - Novartis Investigative Site, Birmingham, United Kingdom - Novartis Investigative Site, Bristol, United Kingdom - Novartis Investigative Site, London, United Kingdom - Novartis Investigative Site, Newcastle upon Tyne, United Kingdom - Novartis Investigative Site, Plymouth, United Kingdom - Novartis Investigative Site, Southampton, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.novartis investigative site|melbourne|victoria|australia` — added _(2026-05-12)_ - `locations.novartis investigative site|nedlands|western australia|australia` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novartis investigative site|parramatta|new south wales|australia` — added _(2026-05-12)_ - `locations.novartis investigative site|sydney|new south wales|australia` — added _(2026-05-12)_ - `locations.novartis investigative site|calgary|alberta|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|vancouver|british columbia|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|victoria|british columbia|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|halifax|nova scotia|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|london|ontario|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|boisbriand|quebec|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.novartis investigative site|olomouc||czechia` — added _(2026-05-12)_ - `locations.novartis investigative site|prague||czechia` — added _(2026-05-12)_ - `locations.novartis investigative site|glostrup municipality||denmark` — added _(2026-05-12)_ - `locations.novartis investigative site|dijon||france` — added _(2026-05-12)_ - `locations.novartis investigative site|lyon||france` — added _(2026-05-12)_ - `locations.novartis investigative site|nice||france` — added _(2026-05-12)_ - `locations.novartis investigative site|paris||france` — added _(2026-05-12)_ - `locations.novartis investigative site|pátrai|greece|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|thessaloniki|greece|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|athens|gr|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|heraklion crete|gr|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|larissa|gr|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|thessaloniki|gr|greece` — added _(2026-05-12)_ - `locations.novartis investigative site|budapest||hungary` — added _(2026-05-12)_ - `locations.novartis investigative site|debrecen||hungary` — added _(2026-05-12)_ - `locations.novartis investigative site|dublin|ireland|ireland` — added _(2026-05-12)_ - `locations.novartis investigative site|dublin||ireland` — added _(2026-05-12)_ - `locations.novartis investigative site|bologna|bo|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|florence|fi|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|milan|mi|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|roma|rm|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|torino|to|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|bari||italy` — added _(2026-05-12)_ - `locations.novartis investigative site|udine||italy` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01599650.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01599650* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*