A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

Sponsor
Hoffmann-La Roche
Study ID
NCT06847542
Phase
PHASE3
Status
Recruiting
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Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Susvimo PDS Implant — DEVICE
    Ranizumab will be administered via a PDS implant per the schedule described in the arm.
  • Ranibizumab — DRUG
    Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.

Study Details

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

Key Dates

First listed
Feb 26, 2025
Start date
Nov 27, 2025
Status verified
Jun 2026
Primary completion
Nov 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Port Delivery System (PDS)
    Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) \[approximately 2-milligrams (mg) dose\] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters [ Time Frame: Baseline, Week 68, Week 72 ]

Central Contacts

  • Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S.)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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