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

ConditionNeovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Initial diagnosis of nAMD within 24 months prior to screening

Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening

Demonstrated response to prior anti-VEGF IVT treatment since diagnosis

Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD

Disqualifiers

History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)

Previous treatment with corticosteroid intravitreal injection

Previous intraocular device implantation

History of vitreous hemorrhage

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Port Delivery System (PDS)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in visual acuity (VA).

Time frame
Baseline, Week 68, Week 72

Secondary outcomes

1

Change From Baseline in BCVA Score Over Time

BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.

Time frame
From baseline up to Week 72
2

Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time

BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.

Time frame
From baseline up to Week 72
3

Change From Baseline in Center Point Thickness (CPT)

Time frame
From baseline up to Week 72
4

Change From Baseline in Central Subfield Thickness (CST)

Time frame
From baseline up to Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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