A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

Conditions

• Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vamikibart — DRUG
  Vamikibart will be administered by IVT injection as specified in each treatment arm.
• Ranibizumab — DRUG
  Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
• Sham Procedure — OTHER
  Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.

Study Details

Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.

Key Dates

First listed

Dec 9, 2021

Start date

Dec 31, 2021

Status verified

Apr 2026

Primary completion

Nov 6, 2024

Completion

Apr 21, 2025

Study Design

Enrollment

394 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: 0.25 mg Vamikibart Q8W
  Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
• Experimental: Arm B: 1.0 mg Vamikibart Q8W
  Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
• Experimental: Arm C: 1.0 mg Vamikibart Q4W
  Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.
• Active Comparator: Arm D: 0.5 mg Ranibizumab Q4W
  Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.

Primary Outcome Measure

Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants [ Time Frame: Baseline, Weeks 44 and 48 ]

Locations (36)

Find similar trials in Arcadia, CA

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