Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye
Condition: Wet Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ranibizumab
Intervention description: All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1049.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: wet AMD; macular degeneration; ranibizumab; mono-bilateral; poor visual acuity; retinal disease; eye disease; Angiogenesis Inhibitors; Angiogenesis Modulating Agents

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients
      affected by wet age related macular degeneration (wAMD).
    

Eligibility criteria:

        Inclusion Criteria

        Male or female patients aged 50 years or above Willing and capable to provide informed
        written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to
        wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated
        (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the
        second eye can be included only if the first eye has been treated at least 14 days before
        with ranibizumab

        Exclusion Criteria:

        Active intraocular inflammation (grade trace or above) in either eye Any ocular or
        periocular active infection (current or suspected), e.g. conjunctivitis, keratitis,
        scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment
        epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may
        confound interpretation of results compromise visual acuity or require medical or surgical
        intervention during the study period including cataract, retinal vascular occlusion,
        retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on
        medication or according to investigator's judgment) History of vitrectomy in the study eye
        History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor
        in the 90 days prior to study enrollment Ocular treatment of the study eye with any
        anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in
        the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS
        using effective contraception during treatment Pregnant or lactating women Simultaneous
        participation in a study that includes administration of any investigational drug Known
        hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability
        to comply with study procedures.