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

Part of paid clinical trials in Arcadia, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05151744
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vamikibart — DRUG
    Vamikibart will be administered by IVT injection in the study eye.
  • Ranibizumab — DRUG
    Ranibizumab will be administered by IVT injection in the study eye.
  • 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.

Study Details

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

Key Dates

First listed
Dec 9, 2021
Start date
Dec 17, 2021
Status verified
Sep 2025
Primary completion
Apr 17, 2024
Completion
Oct 1, 2024

Study Design

Enrollment
187 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Vamikibart + Ranibizumab
    Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
  • Active Comparator: Arm B: Ranibizumab
    Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

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, Week 44 and Week 48 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Win RetinaArcadiaCalifornia91006-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Florida Eye AssociatesMelbourneFlorida30394-7344-
Retina Vitreous Associates of FloridaTampaFlorida33617-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Deep Blue Retina PLLCSouthavenMississippi38671-
Verum Research LLCEugeneOregon97401-
Texas Retina AssociatesArlingtonTexas76012-
Retina Consultants of TexasBellaireTexas77401-

Find similar trials in Arcadia, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Win Retina· Arcadia, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CABay Area Retina Associates· Walnut Creek, CAFlorida Eye Associates· Melbourne, FLRetina Vitreous Associates of Florida· Tampa, FLCumberland Valley Retina Consultants· Hagerstown, MD

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