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 (OCTAVE)

This study is currently recruiting participants.
Verified September 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01780935
First received: January 29, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Drug: Ranibizumab
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Average Visual Acuity [ Time Frame: Month 3 to Month 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in Visual Acuity (Letters) of the Study Eye over time [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Loss of less than 5, 10, and 15 letters in Visual Acuity in the Study Eye from Baseline, at Month 12 and 24 [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Visual Acuity of 73 letters or more in the Study Eye at Month 12 and 24 [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: No ]
  • Average Visual Acuity change from Month 3 to Month 4 through Month 24 in the Study Eye [ Time Frame: Month 3 to Month 24 ] [ Designated as safety issue: No ]
  • Average Visual Acuity change from baseline to Month 1 through Month 12 and 24 in the Study Eye [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye over time [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Dry retina in the Study Eye on OCT at Month 12 and 24 [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in lesion size and morphology based on fluorescein angiography at Month 12 and 24 [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Treatment patterns over time in both treatment arms [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores over time [ Time Frame: Baseline to Month 12 and 24 ] [ Designated as safety issue: No ]
  • Frequency and severity of ocular and non-ocular adverse events over time [ Time Frame: Screening to Month 12 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 670
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCVA loss guided retreatment
0.5 mg intravitreal injections of ranibizumab with retreatment based on BCVA loss due to wet AMD (current EU SmPC label).
Drug: Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab
Experimental: BCVA loss and/or OCT disease activity guided retreatment.
0.5 mg intravitreal injections of ranibizumab with retreatment based on BCVA loss due to wet AMD and/or signs of wet AMD disease activity on OCT.
Drug: Ranibizumab
Intravitreal injections of 0.5 mg Ranibizumab

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Visual impairment predominantly due to neovascular age-related macular degeneration AMD
  • Active, newly diagnosed, untreated CVN lesion 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780935

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 120 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01780935     History of Changes
Other Study ID Numbers: CRFB002A2405, 2011-004959-39
Study First Received: January 29, 2013
Last Updated: September 24, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Guatemala: Ministry of Public Health and Social Assistancê
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Panama: National Commitee of Ethical Investigation
Portugal: National Pharmacy and Medicines Institute
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: Ministry of Health and Social Development

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014