Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab
Intervention description: Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV
      injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of
      ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL,
      40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of
      10-mg/mL formulation) in participants with subfoveal neovascular age-related macular
      degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed with wet AMD within 9 months of screening visit

          -  Participant must have received at least 2 prior ITV anti-vascular endothelial growth
             factor (VEGF) injections. However, the most recent anti-VEGF injection must have been
             ranibizumab and must have occurred at least 7 days prior to the screening visit

          -  Demonstrated response to prior ITV anti-VEGF treatment

          -  Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study
             (ETDRS) charts of 20/20-20/200 Snellen equivalent

        Exclusion Criteria:

          -  Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the
             randomization visit in either eye

          -  Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month
             prior to the randomization visit

          -  History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy
             surgery, submacular surgery, device implantation, or other surgical intervention for
             AMD in the study eye

          -  Prior participation in a clinical trial involving anti-angiogenic drugs, other than
             ranibizumab, in either eye within 2 months of the randomization visit

          -  Subretinal hemorrhage in the study eye that involves the center of the fovea

          -  Subfoveal fibrosis, or atrophy in the study eye

          -  Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular
             histoplasmosis, trauma, or pathologic myopia

          -  Uncontrolled ocular hypertension or glaucoma in the study eye

          -  History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
             in the study eye

          -  Uncontrolled blood pressure

          -  Uncontrolled atrial fibrillation within 3 months of informed consent

          -  History of myocardial infarction or stroke within the last 3 months prior to informed
             consent

          -  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 ranibizumab or placement of the Implant, that might affect
             interpretation of the results of the study or renders the participant at high risk of
             treatment complications

          -  Use of oral corticosteroids

          -  Current treatment for any active systemic infection

          -  Use of anticoagulants, anti-platelets (other than aspirin), or medications known to
             exert similar effects

          -  Active malignancy within 12 months of randomization

          -  History of allergy to fluorescein

          -  Previous participation in any non-ocular (systemic) disease studies of investigational
             drugs within 1 month preceding the informed consent (excluding vitamins and minerals)