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 - Full Text View

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

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:	June 2013
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 75 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

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:	March 26, 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 May 23, 2013

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)