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A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema

NCT05151731•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+2 more criteria

Locations (74)

Win Retina

Arcadia, California, United States

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

Key Dates

Start Date

December 31, 2021

Primary Completion Date

November 6, 2024

Completion Date

April 21, 2025

Last Updated

October 22, 2025

Enrollment

394

ACTUAL participants

Conditions

Diabetic Macular Edema

Interventions

Vamikibart

DRUG

Ranibizumab

DRUG

Sham Procedure

OTHER

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

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RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

A Study of Avoralstat In Participants With Diabetic Macular Edema

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.