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

Conditions

• Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PDS Implant filled with 100 mg/mL Ranibizumab — DRUG
  Will be administered as per the schedule described in individual arm.
• Intravitreal Injections of 10 mg/mL Ranibizumab — DRUG
  Will be administered as per the schedule described in individual arm.

Study Details

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).

Key Dates

First listed

Sep 19, 2018

Start date

Sep 12, 2018

Status verified

Sep 2022

Primary completion

May 22, 2020

Completion

Jun 9, 2021

Study Design

Enrollment

415 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PDS Implant Arm
  Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals
• Active Comparator: Intravitreal Arm
  Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.

Primary Outcome Measure

Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters [ Time Frame: Baseline, and the average of Week 36 and Week 40 ]

Locations (77)

Find similar trials in Mesa, AZ

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