NCT00559715.

Trial name or title	Prevention of Vision Loss in Patients With Age‐Related Macular Degeneration (AMD) by Intravitreal Injection of Bevacizumab and Ranibizumab (VIBERA)
Methods	Study design: phase 3 RCT Planned enrollment: 366 participants Length of follow‐up: 2 years
Participants	Inclusion criteria: age 50 years or older; visual impairment due to active primary or recurrent CNV associated with AMD; classical or predominantly classic lesion with largest diameter of the subretinal neovascular membrane smaller than greatest distance between major temporal vascular arcades, minimally classic lesion, or occult lesion with no classic CNV; BCVA of 20/40 to 20/320 Exclusion criteria: subretinal hemorrhage involving ≥ 50% of the lesion area or ≥ 1 optic disc area; subfoveal fibrosis or atrophy; CNV of other pathogenesis; previous treatment for CNV or treatment with any anti‐angiogenic drugs; previous intravitreal drug delivery, laser photocoagulation, vitreoretinal surgery, submacular surgery, or other surgical intervention for AMD in the study eye; retinal pigment epithelial tear; active inflammation, vitreous hemorrhage, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis; history of rhegmatogenous retinal detachment, macular hole, idiopathic or autoimmune‐associated uveitis, or corneal transplant; aphakia or lack of posterior capsule in the study eye; > ‐8 diopters of myopia; any intraocular condition that requires surgery or could lead to vision loss within 2 years; intraocular surgery in study eye within 2 months; uncontrolled glaucoma or history of glaucoma filtering surgery; impaired visualization of the retina precluding adequate diagnosis; premenopausal women not using adequate contraception or nursing; active systemic infection or other disease, dysfunction, or finding to contraindicate participation; hypersensitivity to study drugs or allergy to agents used for ocular testing; involvement in another clinical study within 4 weeks; unwillingness or inability to comply with study
Interventions	Intervention 1: 1.25 mg intravitreal bevacizumab administered monthly or on demand Intervention 2: 0.5 mg intravitreal ranibizumab administered monthly or on demand
Outcomes	Primary outcome, as defined: proportion of participants losing fewer than 15 letters at 1 year Secondary outcomes, as defined: proportion of participants losing fewer than 15 letters at 2 years; mean change in BCVA at 1 year and at 2 years; proportion of participants with at least 3 months treatment‐free in 2 years; number of doses of study drugs at 2 years; rate of dropout at 2 years; number of non‐responders at 2 years; retinal lesions at 2 years; adverse events at 2 years; quality of life at 2 years
Starting date	August 2008; primary completion date of August 2009
Contact information	Bernd Muehlbauer, Professor, MD Department of Pharmacology at Klinikum Bremen Mitte Bremen, Germany, 28177
Notes	"The study is designed to demonstrate the therapeutic noninferiority of the recombinant humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the treatment of AMD in comparison to the related fragment ranibizumab" Sponsors/Collaborators: Klinikum Bremen‐Mitte, gGmbH; Kompetenzzentrum für Klinische Studien, Bremen

AMD: age‐related macular degeneration
 BCVA: best‐corrected visual acuity
 CNV: choroidal neovascularization
 RCT: randomized controlled trial