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

Last updated: April 30, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Macular Edema

Treatment

Ranibizumab

RO7200220

Sham Procedure

Clinical Study ID

NCT05151731
BP43445
2021-003756-16
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of diabetes mellitus (Type 1 or Type 2)

  • Macular thickening secondary to diabetic macular edema (DME) involving the center ofthe macula

  • Decreased visual acuity attributable primarily to DME

  • Ability and willingness to provide written informed consent and to comply with thestudy protocol

  • Willingness to allow Aqueous Humor collection

  • For women of childbearing potential: agreement to remain abstinent or use at leastone highly effective contraceptive method that results in a failure rate of <1% peryear during the treatment period and for at least 12 weeks after the final dose ofstudy treatment

Exclusion

Exclusion Criteria:

  • Hemoglobin A1c (HbA1c) of greater than (>) 12%

  • Uncontrolled blood pressure, defined as a systolic value greater than (>)180millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient isat 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 weeksprior 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 1to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is notpermitted

  • Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart:

  • Any proliferative diabetic retinopathy

  • Active intraocular or periocular infection or active intraocular inflammation in thestudy eye

  • Any current or history of ocular disease other than DME that may confound assessmentof the macula or affect central vision in the study eye

  • Any current ocular condition which, in the opinion of the investigator, is currentlycausing or could be expected to contribute to irreversible vision loss due to acause other than DME in the study eye

  • Other protocol-specified inclusion/exclusion criteria may apply

Study Design

Total Participants: 394
Treatment Group(s): 4
Primary Treatment: Ranibizumab
Phase: 2
Study Start date:
December 31, 2021
Estimated Completion Date:
April 21, 2025

Connect with a study center

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO
    Argentina

    Site Not Available

  • Centro Oftalmológico Dr. Charles S.A.

    Capital Federal, C1116
    Argentina

    Site Not Available

  • Oftalmos

    Capital Federal, C1120AAN
    Argentina

    Site Not Available

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE
    Argentina

    Site Not Available

  • Centro Privado de Ojos Romagosa

    Cordoba,
    Argentina

    Site Not Available

  • Centro de ojos Loria

    Lomas de Zamora,
    Argentina

    Site Not Available

  • Oftar

    Mendoza, M5500GGK
    Argentina

    Site Not Available

  • Grupo Laser Vision

    Rosario, S2000DLA
    Argentina

    Site Not Available

  • Microcirugía Ocular S.A

    Rosario, S2000CTC
    Argentina

    Site Not Available

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO
    Argentina

    Site Not Available

  • Retina Institute of Ottawa

    Ottawa, Ontario K2B 7E9
    Canada

    Site Not Available

  • The Retina Centre of Ottawa

    Ottawa, Ontario K2B 7E9
    Canada

    Site Not Available

  • Toronto Retina Institute

    Toronto, Ontario M3C 0G9
    Canada

    Site Not Available

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec J7H 0E8
    Canada

    Site Not Available

  • Faculty Hospital Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Faculty Hospital Ostrava; Ophthalmology clinic

    Ostrava, 708 52
    Czechia

    Site Not Available

  • AXON Clinical

    Prague,
    Czechia

    Site Not Available

  • Faculty Hospital Kralovske Vinohrady

    Prague, 100 34
    Czechia

    Site Not Available

  • Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

    Prague, 100 34
    Czechia

    Site Not Available

  • General Teaching Hospital Prague

    Prague, 128 08
    Czechia

    Site Not Available

  • General Teaching Hospital Prague; Ophthalmology clinic

    Prague, 128 08
    Czechia

    Site Not Available

  • Pusan National University Hospital

    Busan, 602-739
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kim's Eye Hospital

    Seoul, 07301
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Centrum Medyczne Julianow

    ?ód?, 91-321
    Poland

    Site Not Available

  • Dobry Wzrok Sp Z O O

    Gda?sk, 80-402
    Poland

    Site Not Available

  • Dobry Wzrok Sp Z O O

    Gdańsk, 80-402
    Poland

    Site Not Available

  • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

    Gliwice, 44-100
    Poland

    Site Not Available

  • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

    Gliwice, 44-100
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Katowice, 40-514
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego

    Katowice, 40-514
    Poland

    Site Not Available

  • Centrum Medyczne UNO-MED

    Krakow, 31-070
    Poland

    Site Not Available

  • SPSK nr 1 w Lublinie

    Lublin, 20-079
    Poland

    Site Not Available

  • SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego

    Lublin, 20-079
    Poland

    Site Not Available

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424
    Poland

    Site Not Available

  • LensClinic

    Rybnik, 44-203
    Poland

    Site Not Available

  • Caminomed

    Tarnowskie Góry, 42-600
    Poland

    Site Not Available

  • Centrum Medyczne Julianow

    Łódź, 91-321
    Poland

    Site Not Available

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Hospital General de Catalunya

    Sant Cugat De Valles, Barcelona 08190
    Spain

    Site Not Available

  • Hospital General de Catalunya; Servicio de oftalmologia

    Sant Cugat De Valles, Barcelona 08190
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Oftalvist Valencia

    Burjassot, Valencia 46100
    Spain

    Site Not Available

  • Hospital Clinico San Carlos; Servicio de oftalmologia

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet; Servicio de Oftalmologia

    Zaragoza, 50009
    Spain

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Bristol Eye Hospital

    Bristol, BS1 2LX
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital

    Guildford, GU2 7XX
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Win Retina

    Arcadia, California 91006
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Retina Consultants, San Diego

    Poway, California 92064
    United States

    Site Not Available

  • Retinal Consultants Med Group

    Sacramento, California 95825
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Colorado Retina Associates, PC

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Emerson Clinical Research Institute LLC

    Washington, District of Columbia 20011-3010
    United States

    Site Not Available

  • Rand Eye

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Pinnacle Research Institute

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Retina Macula Specialists of Miami - LeJeune Road Office

    Miami, Florida 33126-5690
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806-1101
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711-1141
    United States

    Site Not Available

  • Retina Specialists of Tampa

    Wesley Chapel, Florida 33544
    United States

    Site Not Available

  • Butchertown Clinical Trials

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Cumberland Valley Retina PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Tallman Eye Associates

    Lawrence, Massachusetts 01843
    United States

    Site Not Available

  • Deep Blue Retina PLLC

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Opthalmic Consultants of LI

    Lynbrook, New York 11563
    United States

    Site Not Available

  • Buffalo Niagara Retina Associates

    Orchard Park, New York 14127
    United States

    Site Not Available

  • Retina Associates of Western New York

    Rochester, New York 14620
    United States

    Site Not Available

  • University of Rochester Flaum Eye Institute

    Rochester, New York 14642
    United States

    Site Not Available

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Meridian Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44915
    United States

    Site Not Available

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Eye Care Specialists, PC

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Sewickley Eye Group

    Sewickley, Pennsylvania 15143
    United States

    Site Not Available

  • Charleston Neuroscience Institute

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Black Hills Eye Institute

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Retina Consultants of Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Valley Retina Institute P.A.

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Valley Retina Institute P.A.

    McAllen, Texas 78503
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 78240
    United States

    Site Not Available

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Wagner Kapoor Institute

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Wagner Macula & Retina Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.