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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

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 facts

Study ID

NCT05151731

Run by

Hoffmann-La Roche

People needed

394

Starts

2021-12-31

Expected to finish

2025-04-21

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus (Type 1 or Type 2)
• Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
• Decreased visual acuity attributable primarily to DME
• Ability and willingness to provide written informed consent and to comply with the study protocol
• Willingness to allow Aqueous Humor collection
• For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment

You may not qualify if…

• Hemoglobin A1c (HbA1c) of greater than (>) 12%
• Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
• Currently pregnant or breastfeeding, or intend to become pregnant during the study
• Prior treatment with panretinal photocoagulation or macular laser to the study eye
• Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
• Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
• Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo\^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
• Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeks prior to Day 1) in either eye
• Any proliferative diabetic retinopathy
• Active intraocular or periocular infection or active intraocular inflammation in the study eye
• Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
• Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
• Other protocol-specified inclusion/exclusion criteria may apply

Where it is running

• Retina Consultants, San Diego — Poway, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Colorado Retina Associates, PC — Lakewood, Colorado, United States
• Emerson Clinical Research Institute LLC — Washington D.C., District of Columbia, United States
• Rand Eye — Deerfield Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Retina Specialists of Tampa — Wesley Chapel, Florida, United States
• Butchertown Clinical Trials — Louisville, Kentucky, United States
• Cumberland Valley Retina PC — Hagerstown, Maryland, United States
• Deep Blue Retina PLLC — Southaven, Mississippi, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Opthalmic Consultants of LI — Lynbrook, New York, United States
• University of Rochester Flaum Eye Institute — Rochester, New York, United States
• Western Carolina Retinal Associate PA — Asheville, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Meridian Clinical Research — Cincinnati, Ohio, United States
• Verum Research LLC — Eugene, Oregon, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Erie Retinal Surgery — Erie, Pennsylvania, United States
• Eye Care Specialists, PC — Kingston, Pennsylvania, United States
• Sewickley Eye Group — Sewickley, Pennsylvania, United States
• Win Retina — Arcadia, California, United States

Full record on ClinicalTrials.gov

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