Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zifibancimig — DRUG
  Part 1: multiple ascending doses by IVT injection. Each participant will receive zifibancimig at a constant volume of 50 microliter (µL) in the study eye. Part 2: participants will be randomized to one of two dose levels of zifibancimig in the PD implant. Part 3: Participants will receive one of the two dose levels of zifibancimig in the PD implant.
• Ranibizumab — DRUG
  Participants will receive ranibizumab 100 mg/mL through the PD implant
• Port Delivery Platform — DEVICE
  Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous.

Study Details

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).

Key Dates

First listed

Sep 28, 2020

Start date

Oct 28, 2020

Status verified

May 2026

Primary completion

Aug 1, 2026

Completion

Aug 1, 2026

Study Design

Enrollment

177 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: IVT Injections
  Zifibancimig administered in multiple ascending dose levels through IVT injections.
• Experimental: Part 2: PD With High Dose
  Zifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 milligrams per milliliter (mg/mL), administered through the PD implant.
• Experimental: Part 2: PD With Low Dose
  Zifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through the PD implant.
• Experimental: Part 3: PD With High Dose
  Zifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant.
• Experimental: Part 3: PD With Low Dose
  Zifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant.
• Active Comparator: Part 3: PD With Ranibizumab
  100 mg/mL of ranibizumab administered through the PD implant.

Primary Outcome Measure

Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) [ Time Frame: Part 1: Baseline up to Week 24; Parts 2 & 3: Baseline up to Week 48 ]

Locations (38)

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