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

Neovascular Age-related Macular Degeneration Clinical Trial

— OCTAVE  

Official title:

A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780935
• Other study ID #: CRFB002A2405
• Secondary ID: 2011-004959-39
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2013
• Last updated: October 9, 2015
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of HealthCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareGuatemala: Ministry of Public Health and Social AssistancêHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: The Italian Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Panama: National Commitee of Ethical InvestigationPortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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 qualifiying vision score at study entry

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Austria	Novartis Investigative Site	Wien
Canada	Novartis Investigative Site	Boisbriand	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	Vancouver	British Columbia
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Colombia	Novartis Investigative Site	Medellin	Antioquia
Czech Republic	Novartis Investigative Site	Brno
Czech Republic	Novartis Investigative Site	Hradec Kralove
Czech Republic	Novartis Investigative Site	Olomouc	CZE
Czech Republic	Novartis Investigative Site	Praha 10
Finland	Novartis Investigative Site	HUS
Finland	Novartis Investigative Site	Kuopio
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Regensburg
Greece	Novartis Investigative Site	Ampelokipi	Athens
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Glyfada	Athens
Greece	Novartis Investigative Site	Ioannina
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Veszprem
Hungary	Novartis Investigative Site	Zalaegerszeg
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Waterford
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Udine	UD
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Vilnius
Mexico	Novartis Investigative Site	Ciudad De Mexico	Distrito Federal
Netherlands	Novartis Investigative Site	Den Bosch
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Rotterdam
Panama	Novartis Investigative Site	Panama City	Panamá
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Nitra
Slovakia	Novartis Investigative Site	Trencin
Slovakia	Novartis Investigative Site	Zilina
Slovakia	Novartis Investigative Site	Zvolen
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Sweden	Novartis Investigative Site	Linköping
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Genève
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Zuerich
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Cheshire
United Kingdom	Novartis Investigative Site	Derby
United Kingdom	Novartis Investigative Site	Frimley	Surrey
United Kingdom	Novartis Investigative Site	Gloucester
United Kingdom	Novartis Investigative Site	Great Yarmouth
United Kingdom	Novartis Investigative Site	Guildford, Surrey
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Middlesborough
United Kingdom	Novartis Investigative Site	Rugby
United Kingdom	Novartis Investigative Site	Southampton
United Kingdom	Novartis Investigative Site	Wolverhampton
United Kingdom	Novartis Investigative Site	York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Austria,  Canada,  Colombia,  Czech Republic,  Finland,  France,  Germany,  Greece,  Guatemala,  Hungary,  Ireland,  Italy,  Lithuania,  Mexico,  Netherlands,  Panama,  Portugal,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Average Visual Acuity	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 across all visits from Month 4 through 12 and the Month 3 Level of VA (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.	Month 3 to Month 12	No
Secondary	Change from Baseline in Visual Acuity (Letters) of the Study Eye over time		Baseline to Month 12 and 24	No
Secondary	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	No
Secondary	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	No
Secondary	Visual Acuity of 73 letters or more in the Study Eye at Month 12 and 24		Month 12 and 24	No
Secondary	Average Visual Acuity change from Month 3 to Month 4 through Month 24 in the Study Eye		Month 3 to Month 24	No
Secondary	Average Visual Acuity change from baseline to Month 1 through Month 12 and 24 in the Study Eye		Baseline to Month 12 and 24	No
Secondary	Change from Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye over time		Baseline to Month 12 and 24	No
Secondary	Dry retina in the Study Eye on OCT at Month 12 and 24		Month 12 and 24	No
Secondary	Change from Baseline in lesion size and morphology based on fluorescein angiography at Month 12 and 24		Baseline to Month 12 and 24	No
Secondary	Treatment patterns over time in both treatment arms		Baseline to Month 12 and 24	No
Secondary	Change from Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores over time		Baseline to Month 12 and 24	No
Secondary	Frequency and severity of ocular and non-ocular adverse events over time		Screening to Month 12 and 24	Yes