Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
Condition: Age-related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab 0.5mg; Ranibizumab 0.5mg
Intervention description: 0.5 mg ranibizumab (intravitreal injections) prefilled syringe); 0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 650.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen

Summary:

      This study was designed to evaluate the efficacy and safety of two different regimens of 0.5
      mg ranibizumab given as intravitreal injection in patients with neovascular age-related
      macular degeneration
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female patients, ≥50 years of age with signed informed consent before study
             procedures

          -  Visual impairment predominantly due to nAMD.

          -  Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by
             fluorescein angiography (FA) and/or color fundus photography

          -  Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT

          -  BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early
             Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate
             Snellen equivalent of 20/32 and 20/320)

        Key Exclusion Criteria:

          -  Any type of advanced, severe or unstable disease, including any medical condition
             (controlled or uncontrolled) that could be expected to progress, recur, or change to
             such an extent that it may bias the assessment of the clinical status of the patient
             to a significant degree or put the patient at special risk.

          -  Stroke or myocardial infarction within 3 months prior to Screening.

          -  Any active periocular or ocular infection or inflammation in both eyes.

          -  Ocular disorders in the study eye at the time of enrollment that may confound
             interpretation of study results and compromise visual acuity.

          -  Presence of amblyopia or amaurosis in the fellow eye.

          -  History of treatment with any anti-angiogenic drugs (including any anti- vascular
             endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®],
             aflibercept [Eylea®]) or vPDT in the study eye.

          -  History of intravitreal treatment with corticosteroids within 6 months and history of
             intra-ocular surgery within 3 months in the study eye prior to the Screening.

          -  Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as
             all women physiologically capable of becoming pregnant, unless they are using
             effective methods of contraception during dosing of study treatment.