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

NCT01599650 | Completed Phase 3 Results

• 2 other identifiers: CRFB002E24022011-002859-34
• Study Type: interventional
• Target: 455
• Locations: 17 countries
• Sites: 82

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.

Conditions

Branch Retinal Vein Occlusion

Keywords

Macular Edema, Branch Retinal Vein Occlusion, visual impairment

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Baseline, 6 Months

Secondary Outcomes (10)

• The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline

  Baseline, 24 Months

• Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group

  Day 1 through Month 23

• Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6

  From Baseline through Month 6

• The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24

  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

  Baseline, Month 6 and Month 24

Study Arms (3)

1-ranibizumab monotherapy

EXPERIMENTAL

Ranibizumab 0.5 mg

Drug: Ranibizumab

2-ranibizumab with laser

EXPERIMENTAL

Ranibizumab 0.5 mg + laser

Drug: Ranibizumab; Procedure: Laser

3-laser monotherapy

ACTIVE COMPARATOR

Laser monotherapy with Ranibizumab 0.5 mg from Month 6

Procedure: Laser

Interventions

Ranibizumab DRUG

Also known as: Lucentis

1-ranibizumab monotherapy; 2-ranibizumab with laser

Laser PROCEDURE

laser photocoagulation

2-ranibizumab with laser; 3-laser monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (82)

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

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Novartis Investigative Site

Sydney, New South Wales, 2000, Australia

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Melbourne, Victoria, 3002, Australia

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Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

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Calgary, Alberta, T2H0C8, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8V 4X3, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 4G5, Canada

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Boisbriand, Quebec, J7H 1S6, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Novartis Investigative Site

Olomouc, 775 20, Czechia

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Prague, 100 34, Czechia

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Glostrup Municipality, DK-2600, Denmark

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Dijon, 21033, France

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Lyon, 69003, France

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Nice, 06000, France

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Paris, 75010, France

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Paris, 75940, France

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Paris, France

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Novartis Investigative Site

Pátrai, Greece, 26504, Greece

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Thessaloniki, Greece, GR 54636, Greece

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Novartis Investigative Site

Athens, GR, 124 62, Greece

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Novartis Investigative Site

Heraklion Crete, GR, 711 10, Greece

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Novartis Investigative Site

Larissa, GR, 411 10, Greece

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Novartis Investigative Site

Thessaloniki, GR, 546 29, Greece

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Budapest, 1133, Hungary

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Budapest, H-1083, Hungary

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Debrecen, 4032, Hungary

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Dublin, Ireland, Ireland

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Dublin, Ireland

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Florence, FI, 50134, Italy

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Milan, MI, 20100, Italy

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Milan, MI, 20132, Italy

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Roma, RM, 00144, Italy

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Novartis Investigative Site

Torino, TO, 10122, Italy

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Bari, 70124, Italy

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Udine, 33100, Italy

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Novartis Investigative Site

Leiden 2333 ZA, Netherlands, 2333, Netherlands

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Rotterdam, 3011 BH, Netherlands

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Novartis Investigative Site

Tilburg, 5022 GC, Netherlands

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Novartis Investigative Site

Bielsko-Biala, 43-300, Poland

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Gdansk, 80-809, Poland

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Novartis Investigative Site

Krakow, 31-501, Poland

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Lublin, 20-079, Poland

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Novartis Investigative Site

Warsaw, 02-005, Poland

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Novartis Investigative Site

Wroclaw, 50-556, Poland

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Novartis Investigative Site

Porto, Porto District, 4200-319, Portugal

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Novartis Investigative Site

Coimbra, Portugal, 3000-354, Portugal

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Novartis Investigative Site

Coimbra, Portugal, 3030-163, Portugal

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Novartis Investigative Site

Porto, Portugal, 4099-001, Portugal

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Novartis Investigative Site

Lisbon, 1050-085, Portugal

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Novartis Investigative Site

Lisbon, 1349-019, Portugal

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Novartis Investigative Site

Žilina, Slovak Republic, 010 01, Slovakia

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Novartis Investigative Site

Bratislava, Slovakia, 826 06, Slovakia

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Novartis Investigative Site

Banská Bystrica, 975 17, Slovakia

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Novartis Investigative Site

Bratislava, 851 07, Slovakia

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Novartis Investigative Site

Bilbao, Basque Country, 48006, Spain

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Valladolid, Castille and León, 47011, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08022, Spain

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Barcelona, Catalonia, Spain

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Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Madrid, Madrid, 28046, Spain

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Novartis Investigative Site

Alicante, Valencia, 03016, Spain

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Novartis Investigative Site

Valencia, Valencia, 46014, Spain

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Novartis Investigative Site

Valencia, Valencia, 46015, Spain

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Novartis Investigative Site

Örebro, 701 85, Sweden

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Novartis Investigative Site

Olten, Switzerland, 4600, Switzerland

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Novartis Investigative Site

Zurich, Switzerland, 8063, Switzerland

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Novartis Investigative Site

Bern, 3012, Switzerland

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Novartis Investigative Site

Lausanne, 1007, Switzerland

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Novartis Investigative Site

Frimley, Surrey, GU16 7UJ, United Kingdom

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Novartis Investigative Site

London, United Kingdom, EC1V 2PD, United Kingdom

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Novartis Investigative Site

Belfast, BT12 6BA, United Kingdom

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Novartis Investigative Site

Birmingham, B9 5SS, United Kingdom

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Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

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Novartis Investigative Site

London, NW1 5QH, United Kingdom

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Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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Novartis Investigative Site

Plymouth, PL4 6PL, United Kingdom

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Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

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Related Publications (3)

• Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.

  PMID: 34934034 DERIVED

• Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12.

  PMID: 28807635 DERIVED

• Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.

  PMID: 27039022 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema; Vision Disorders

Interventions

Ranibizumab; Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 10, 2016
• Results First Posted: November 10, 2016

Record last verified: 2016-09

Locations

GB (9); SL (4); NL (3); GR (6); CA (7); FR (6); ES (10); IT (8); AU (4); HU (3); SE (1); IE (2); PT (6); DK (1); PL (6); CH (4); CZ (2)