A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: PDS Implant filled with 100 mg/mL Ranibizumab; Intravitreal Injections of 10 mg/mL Ranibizumab
Intervention description: Will be administered as per the schedule described in individual arm.; Will be administered as per the schedule described in individual arm.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor
      [VA]-masked), active-comparator study designed to assess the efficacy, safety, and
      pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab
      (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants
      with neovascular age-related macular degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥50 years, at time of signing Informed Consent Form

          -  Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD)
             within 9 months prior to the screening visit

          -  Previous treatment with at least three anti-vascular endothelial growth factor
             (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months
             prior to the screening visit

          -  Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis

          -  Best-corrected visual acuity (BCVA) of 34 letters or better

        Exclusion Criteria:

          -  Subfoveal fibrosis or subfoveal atrophy in study eye

          -  Subretinal hemorrhage that involves the center of the fovea in study eye

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD in study eye

          -  Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary
             thermotherapy in study eye

          -  Previous intraocular device implantation in study eye

          -  Previous laser (any type) used for AMD treatment in study eye

          -  Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the
             randomization visit in either eye

          -  Prior participation in a clinical trial involving anti-VEGF drugs within 6 months
             prior to the randomization visit, other than ranibizumab in either eye

          -  CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
             in either eye

          -  Uncontrolled blood pressure

          -  History of stroke within the last 3 months prior to informed consent

          -  Uncontrolled atrial fibrillation within 3 months of informed consent

          -  History of myocardial infarction within the last 3 months prior to informed consent

          -  History of other disease, metabolic dysfunction, or clinical laboratory finding giving
             reasonable suspicion of a disease or condition that contraindicates the use of
             ranibizumab or placement of the Implant and that might affect interpretation of the
             results of the study or renders the participant at high risk of treatment
             complications in the opinion of the investigator

          -  Current systemic treatment for a confirmed active systemic infection

          -  Chronic use of oral corticosteroids

          -  Active cancer within 12 months of randomization

          -  Previous participation in any non-ocular (systemic) disease studies of investigational
             drugs within 1 month preceding the informed consent (excluding vitamins and minerals)