Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

NCT01780935 | Completed Phase 3 Results

• 2 other identifiers: CRFB002A24052011-004959-39
• Study Type: interventional
• Target: 671
• Locations: 24 countries
• Sites: 92

Brief Summary

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12

  Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.

  up to Month 12

Secondary Outcomes (12)

• Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12

  up to Month 12

• Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24

  Baseline to Month 12 and 24

• Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24

  Baseline to Month 12 and 24

• Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24

  Month 12 and 24

• Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye

  Month 3 to Month 24

Study Arms (2)

RBZ 0.5 mg: VA only (Group I)

EXPERIMENTAL

RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)

Drug: Ranibizumab

RBZ 0.5 mg: VA and/or OCT (Group II)

EXPERIMENTAL

RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal injections of 0.5 mg Ranibizumab

RBZ 0.5 mg: VA and/or OCT (Group II); RBZ 0.5 mg: VA only (Group I)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual impairment predominantly due to neovascular age-related macular degeneration AMD
• Active, newly diagnosed, untreated CNV due to AMD
• CNV involving the center of the retina
• A qualifying vision score at study entry

You may not qualify if:

• Stroke or myocardial infarction less than 3 Months prior to study entry
• Active injection or inflammation of either eye at the time of study entry

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (92)

Novartis Investigative Site

Buenos Aires, C1122AAI, Argentina

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Novartis Investigative Site

Ciudad Autonoma de Bs As, C1015ABO, Argentina

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Vienna, 1090, Austria

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Vancouver, British Columbia, V5Z 3N9, Canada

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Novartis Investigative Site

Halifax, Nova Scotia, B3H 2E1, Canada

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Novartis Investigative Site

London, Ontario, N6A 4G5, Canada

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Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

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Novartis Investigative Site

Boisbriand, Quebec, J7H 1S6, Canada

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Novartis Investigative Site

Sherbrooke, Quebec, J1J 2B8, Canada

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Novartis Investigative Site

Medellín, Antioquia, 001, Colombia

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Novartis Investigative Site

Bogotá, Cundinamarca, 7550000, Colombia

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Novartis Investigative Site

Olomouc, CZE, 775 20, Czechia

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Novartis Investigative Site

Brno, 625 00, Czechia

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Novartis Investigative Site

Hradec Králové, 505 05, Czechia

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Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

HUS, 00029, Finland

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Novartis Investigative Site

Kuopio, 70211, Finland

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Novartis Investigative Site

Paris, 75015, France

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Novartis Investigative Site

Bonn, 53127, Germany

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Chemnitz, 09113, Germany

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Cologne, 50924, Germany

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Darmstadt, 64297, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

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Novartis Investigative Site

München, 80336, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Regensburg, 93053, Germany

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Novartis Investigative Site

Ampelokipoi, Athens, 11 526, Greece

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Novartis Investigative Site

Glyfada, Athens, 16675, Greece

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Novartis Investigative Site

Athens, GR, 156 69, Greece

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Novartis Investigative Site

Ioannina, 45500, Greece

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Novartis Investigative Site

Guatemala City, 01009, Guatemala

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Novartis Investigative Site

Guatemala City, 01010, Guatemala

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Novartis Investigative Site

Budapest, 1076, Hungary

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Novartis Investigative Site

Budapest, 1083, Hungary

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Novartis Investigative Site

Budapest, 1106, Hungary

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Novartis Investigative Site

Budapest, 1133, Hungary

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Novartis Investigative Site

Budapest, 1145, Hungary

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Debrecen, 4012, Hungary

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Novartis Investigative Site

Szeged, H-6725, Hungary

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Novartis Investigative Site

Veszprém, H-8200, Hungary

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Novartis Investigative Site

Zalaegerszeg, 8900, Hungary

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Novartis Investigative Site

Dublin, Ireland

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Novartis Investigative Site

Waterford, Ireland

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Novartis Investigative Site

Florence, FI, 50134, Italy

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Novartis Investigative Site

Milan, MI, 20100, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Udine, UD, 33100, Italy

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Novartis Investigative Site

Kaunas, LTU, 50009, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

Mexico City, Mexico City, 06800, Mexico

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Novartis Investigative Site

's-Hertogenbosch, 5223 GZ, Netherlands

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Novartis Investigative Site

Nijmegen, 6525 EX, Netherlands

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Novartis Investigative Site

Rotterdam, 3011 BH, Netherlands

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Novartis Investigative Site

Panama City, 0819-12316, Panama

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Novartis Investigative Site

Coimbra, 3000-354, Portugal

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Novartis Investigative Site

Lisbon, 1050-085, Portugal

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Novartis Investigative Site

Porto, 4200-319, Portugal

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Novartis Investigative Site

Bratislava, 82606, Slovakia

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Novartis Investigative Site

Bratislava, 85107, Slovakia

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Novartis Investigative Site

Nitra, 94901, Slovakia

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Novartis Investigative Site

Trenčín, 91171, Slovakia

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Novartis Investigative Site

Zvolen, 960 01, Slovakia

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Novartis Investigative Site

Žilina, 01207, Slovakia

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Novartis Investigative Site

Bilbao, Basque Country, 48006, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Oviedo, Principality of Asturias, 33012, Spain

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Novartis Investigative Site

Barcelona, 08025, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Novartis Investigative Site

Linköping, SE-581 85, Sweden

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Novartis Investigative Site

Bern, 3012, Switzerland

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Novartis Investigative Site

Geneva, 1204, Switzerland

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Novartis Investigative Site

Lausanne, 1007, Switzerland

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Novartis Investigative Site

Zurich, 8063, Switzerland

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Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, 06490, Turkey (Türkiye)

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Novartis Investigative Site

Frimley, Surrey, GU16 7UJ, United Kingdom

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Novartis Investigative Site

Belfast, BT12 6BA, United Kingdom

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Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

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Novartis Investigative Site

Cheshire, CW14QJ, United Kingdom

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Novartis Investigative Site

Derby, DE22 3NE, United Kingdom

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Novartis Investigative Site

Gloucester, GL1 3NN, United Kingdom

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Novartis Investigative Site

Great Yarmouth, NR31 6LA, United Kingdom

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Novartis Investigative Site

Guildford, Surrey, GU2 5XX, United Kingdom

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Novartis Investigative Site

Hull, HU3 2JZ, United Kingdom

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Novartis Investigative Site

London, EC1V 2PD, United Kingdom

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Novartis Investigative Site

London, SE5 9RS, United Kingdom

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Novartis Investigative Site

Middlesbrough, TS4 3BW, United Kingdom

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Novartis Investigative Site

Rugby, CV22 5PX, United Kingdom

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Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Novartis Investigative Site

York, YO31 8HE, United Kingdom

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Related Publications (1)

• Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.

  PMID: 31918685 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Use of optical coherence tomography guided therapy in the treatment of neovascular age related macular degeneration became standard of care by HA \& Ophth. community during the time this trial was conducted.Novartis terminated this trial.

Results Point of Contact

• Title: Study Director
• 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: June 3, 2013
• Primary Completion: July 9, 2015
• Study Completion: July 9, 2015
• Last Updated: August 14, 2017
• Results First Posted: January 2, 2017

Record last verified: 2017-07

Locations

FR (1); GU (2); SL (6); DE (9); SE (1); LI (2); CZ (4); GR (4); AU (1); NL (3); CO (2); ME (1); IE (2); FI (2); PT (3); PA (1); ES (5); CH (4); GB (16); AR (2); IT (4); HU (9); TU (2); CA (6)