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)

July 4, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1122AAI
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Argentina, C1015ABO
        • Novartis Investigative Site
  • Austria
      • Wien, Austria, 1090
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Novartis Investigative Site
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 1S6
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada, J1J 2B8
        • Novartis Investigative Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 001
        • Novartis Investigative Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 7550000
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 625 00
        • Novartis Investigative Site
      • Hradec Kralove, Czechia, 505 05
        • Novartis Investigative Site
      • Praha 10, Czechia, 100 34
        • Novartis Investigative Site
    • CZE
      • Olomouc, CZE, Czechia, 775 20
        • Novartis Investigative Site
  • Finland
      • HUS, Finland, 00029
        • Novartis Investigative Site
      • Kuopio, Finland, 70211
        • Novartis Investigative Site
  • France
      • Paris, France, 75015
        • Novartis Investigative Site
  • Germany
      • Bonn, Germany, 53127
        • Novartis Investigative Site
      • Chemnitz, Germany, 09113
        • Novartis Investigative Site
      • Darmstadt, Germany, 64297
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Muenster, Germany, 48145
        • Novartis Investigative Site
      • München, Germany, 80336
        • Novartis Investigative Site
      • Regensburg, Germany, 93053
        • Novartis Investigative Site
  • Greece
      • Ioannina, Greece, 45500
        • Novartis Investigative Site
    • Athens
      • Ampelokipi, Athens, Greece, 11 526
        • Novartis Investigative Site
      • Glyfada, Athens, Greece, 16675
        • Novartis Investigative Site
    • GR
      • Athens, GR, Greece, 156 69
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01009
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1145
        • Novartis Investigative Site
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Budapest, Hungary, 1106
        • Novartis Investigative Site
      • Budapest, Hungary, 1133
        • Novartis Investigative Site
      • Budapest, Hungary, 1076
        • Novartis Investigative Site
      • Debrecen, Hungary, 4012
        • Novartis Investigative Site
      • Szeged, Hungary, H-6725
        • Novartis Investigative Site
      • Veszprem, Hungary, H-8200
        • Novartis Investigative Site
      • Zalaegerszeg, Hungary, 8900
        • Novartis Investigative Site
  • Ireland
      • Dublin, Ireland
        • Novartis Investigative Site
      • Waterford, Ireland
        • Novartis Investigative Site
  • Italy
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
      • Milano, MI, Italy, 20100
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italy, 33100
        • Novartis Investigative Site
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
    • LTU
      • Kaunas, LTU, Lithuania, 50009
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • Ciudad De Mexico, Distrito Federal, Mexico, 06800
        • Novartis Investigative Site
  • Netherlands
      • Den Bosch, Netherlands, 5223 GZ
        • Novartis Investigative Site
      • Nijmegen, Netherlands, 6525 EX
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3011 BH
        • Novartis Investigative Site
  • Panama
      • Panama City, Panama, 0819-12316
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-354
        • Novartis Investigative Site
      • Lisboa, Portugal, 1050-085
        • Novartis Investigative Site
      • Porto, Portugal, 4200-319
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 85107
        • Novartis Investigative Site
      • Bratislava, Slovakia, 82606
        • Novartis Investigative Site
      • Nitra, Slovakia, 94901
        • Novartis Investigative Site
      • Trencin, Slovakia, 91171
        • Novartis Investigative Site
      • Zilina, Slovakia, 01207
        • Novartis Investigative Site
      • Zvolen, Slovakia, 960 01
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08025
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48006
        • Novartis Investigative Site
  • Sweden
      • Linköping, Sweden, SE-581 85
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3012
        • Novartis Investigative Site
      • Genève, Switzerland, 1204
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1007
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8063
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06490
        • Novartis Investigative Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Novartis Investigative Site
      • Bristol, United Kingdom, BS1 2LX
        • Novartis Investigative Site
      • Cheshire, United Kingdom, CW14QJ
        • Novartis Investigative Site
      • Derby, United Kingdom, DE22 3NE
        • Novartis Investigative Site
      • Gloucester, United Kingdom, GL1 3NN
        • Novartis Investigative Site
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Novartis Investigative Site
      • Guildford, Surrey, United Kingdom, GU2 5XX
        • Novartis Investigative Site
      • Hull, United Kingdom, HU3 2JZ
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, EC1V 2PD
        • Novartis Investigative Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Novartis Investigative Site
      • Rugby, United Kingdom, CV22 5PX
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site
      • York, United Kingdom, YO31 8HE
        • Novartis Investigative Site
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 qualifying 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RBZ 0.5 mg: VA only (Group I)
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
Intravitreal injections of 0.5 mg Ranibizumab
Experimental: RBZ 0.5 mg: VA and/or OCT (Group II)
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
Intravitreal injections of 0.5 mg Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12
Time Frame: up to Month 12
Visual acuity (VA) was assessed 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 from Baseline to Month 12 Level of VA (Letters) of the Study Eye.
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
Time Frame: Baseline to Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
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
Time Frame: Baseline to Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24
Time Frame: Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Month 12 and 24
Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye
Time Frame: Month 3 to Month 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Month 3 to Month 24
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
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
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
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
Dry Retina in the Study Eye on OCT at Month 12 and 24
Time Frame: Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Month 12 and 24
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
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
Treatment Patterns Over Time in Both Treatment Arms
Time Frame: Baseline to Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
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
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Baseline to Month 12 and 24
Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time
Time Frame: Screening to Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Screening to Month 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2013

Primary Completion (Actual)

July 9, 2015

Study Completion (Actual)

July 9, 2015

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002A2405
  • 2011-004959-39 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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