VIBERA: Prevention of Vision Loss in Patients With Age-Related Macular Degeneration (AMD) by Intravitreal Injection of Bevacizumab and Ranibizumab

Sponsor

Klinikum Bremen-Mitte, gGmbH (Other)

Overall Status

Unknown status

CT.gov ID

NCT00559715

Collaborator

Kompetenzzentrum für Klinische Studien, Bremen (Other)

366

Enrollment

Location

Arms

Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Neovascular Macular Degeneration	Drug: bevacizumab Drug: ranibizumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2009

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: bevacizumab 1.25 mg intravitreally monthly/on demand Other Names: Avastin®
Active Comparator: B	Drug: ranibizumab 0.5 mg intravitreally monthly/on demand Other Names: Lucentis®

Arm

Intervention/Treatment

Experimental: A

Drug: bevacizumab

1.25 mg intravitreally monthly/on demand

Other Names:

Avastin®

Active Comparator: B

Drug: ranibizumab

0.5 mg intravitreally monthly/on demand

Other Names:

Lucentis®

Outcome Measures

Primary Outcome Measures

Proportion of patients with a loss of fewer than 15 letters at month 12 [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Retinal pigment epithelial tear involving the macula in the study eye
Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either:
require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or
if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-month study period
Active intraocular, ocular, or periocular inflammation (any grade "trace" or above) in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
History of idiopathic or autoimmune-associated uveitis in either eye
Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Aphakia or absence of the posterior capsule in the study eye
Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding day 0
Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] of 30 mmHg or more despite treatment with antiglaucoma medications)
History of glaucoma filtering surgery in the study eye
History of corneal transplant in the study eye
Premenopausal women not using adequate contraception
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
Current treatment for active systemic infection
History of allergy to fluorescein, not amenable to treatment with diphenhydramine
Inability to obtain fundus photographs or FA of sufficient quality to be analyzed and graded by the blinded evaluation center
Inability to comply with study or follow-up procedures