Prevention of Vision Loss in Patients With Age-Related Neovascular Macular Degeneration by Intravitreal Injection of Bevacizumab and Ranibizumab in a Typical Outpatient Setting

Klinikum Bremen-Mitte, gGmbH1 site in 1 country366 target enrollmentAugust 2008

ConditionsAge-Related Neovascular Macular Degeneration

Interventionsbevacizumab ranibizumab

Drugsbevacizumab ranibizumab

Overview

Phase: Phase 3
Intervention: bevacizumab
Conditions: Age-Related Neovascular Macular Degeneration
Sponsor: Klinikum Bremen-Mitte, gGmbH
Enrollment: 366
Locations: 1
Primary Endpoint: Proportion of patients with a loss of fewer than 15 letters at month 12
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to demonstrate the therapeutic non-inferiority of the recombinant humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the treatment of AMD in comparison to the related fragment ranibizumab.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Klinikum Bremen-Mitte, gGmbH

Eligibility Criteria

Inclusion Criteria

•Patients with visual impairment (best corrected visual acuity of 20/40 to 20/320 (Snellen equivalent, ETDRS chart)) due to an active primary or recurrent CNV associated with age-related macular degeneration involving the foveal center, presenting with either:
•a classical / predominantly classical lesion with largest diameter of SNVM smaller than greatest distance between major temporal vascular arcades or
•a minimally classical lesion or an occult lesion with no classic choroidal neovascularization

Exclusion Criteria

•Known or suspected hypersensitivity to ranibizumab or bevacizumab
•Participation in any clinical trial within the last 4 weeks
•Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, bevacizumab ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
•Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
•Previous subfoveal focal laser photocoagulation in the study eye
•Previous laser photocoagulation (juxtafoveal or extrafoveal) in the study eye
•History of vitreoretinal surgery in the study eye
•History of submacular surgery or other surgical intervention for AMD in the study eye
•Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
•Subfoveal fibrosis or atrophy in the study eye

Arms & Interventions

A

Intervention: bevacizumab

B

Intervention: ranibizumab

Outcomes

Primary Outcomes

Proportion of patients with a loss of fewer than 15 letters at month 12

Time Frame: 1 year

Secondary Outcomes

Proportion of patients with a loss of fewer than 15 letters at month 24(2 years)
Mean change from baseline in BCVA at month 12 (IA) and month 24(2 years)
Proportion of patients with a treatment-free interval of at least 3 months' duration at any time point following month 2(2 years)
Number of doses of the study drugs(2 years)
Drop out rates(2 years)
Rate of non-responders(2 years)
Retinal lesions(2 years)
Adverse Events(2 years)
Quality of Life(2 years)