A randomized observer and subject masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degenerationMulticenter Anti VEGF Trial in Austria (MANTA) - MANTA

• Conditions: Subjects of either gender, aged> 50 years, presenting with subfoveal choroidal neovascularization due to age-related macular degeneration

• Registration Number: EUCTR2007-005157-33-AT
• Lead Sponsor: udwig Boltzmann Institut für Retinologie und biomikroskopische Laserchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Age = 50 years
Active primary or recurrent subfoveal lesion with CNV secondary to AMD, activity to be proven by fluorescein angiography as described previously (Rosenfeld et al. 2006).
Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior treatment with any intravitreal drug in the study eye
Prior treatment with verteporfin photodynamic therapy in the study eye
Prior treatment with systemic bevacizumab
Prior treatment with any intravitreal durg or verteprofin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
Laser photocoagulation within 1 month before study entry in the study eye
Previous participation in any clinical trial within 1 month before the entry of the study
Subfoveal fibrosis or atrophy in the study eye
CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathologica myopia
Retinal pigment epithelial tear involving the macula in the study eye
Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
Active intraocular inflammation
Vitreous hemorrhage in the study eye
History of rhematogenous retinal detachment or stage 3 or 4 macula hole in the study eye
History of idiopathic or autoimmune-asscoaited uveitis in either eye
Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
Aphakia or absence of the posterior capsule in the study eye
Intraocular surgery in the study eye within 2 months before the entry of the study
History of corneal transplant in the study eye
History of myocardial infaraction and/or stroke
History of any ocular or systemic disease that according to the opinion of the local principal investiagtor may affect the interpretation of the study results or render the subject at high risk for treatment complications
History of allergy to fluorescein, not amendable with diphenhydramine
Inability to comply with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Mean change in VA over time (ETDRS charts);Secondary Objective: Kaplan-Meier proportions of the loss of 15 letters of vision (ETDRS charts)Kaplan-Meier proportions of the loss of 5 letters of vision (ETDRS charts)Proportion of patients gaining = 0, = 1, = 2 and = 3 lines in vision (ETDRS charts)Number of total injectionsLesion size, total choroidal neovascularization, leak area and area of serous sensory retinal detachment (fluorescein angiography)Retinal thickness (optical coherence tomography)Adverse events;Primary end point(s): distance visual acuity at month 12