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NCT05151731CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
394 (actual)
First submitted
8 Dec 2021
Start date
31 Dec 2021
Primary completion date
6 Nov 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05151731
EudraCT number
2021-003756-16

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 394
  • From 31 Dec 2021 to the primary completion date, 6 Nov 2024
  • 74 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

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

Other

  • 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
  • Any proliferative diabetic retinopathy
  • Other protocol-specified inclusion/exclusion criteria may apply

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Organización Médica de Investigación
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Buenos AiresArgentinaUnknown status
Centro Oftalmologico Dr. Charles S.A.
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Capital FederalArgentinaUnknown status
Oftalmos
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Capital FederalArgentinaUnknown status
Buenos Aires Mácula
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Centro Privado de Ojos Romagosa
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CórdobaArgentinaUnknown status
Centro de ojos Loria
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Lomas de ZamoraArgentinaUnknown status
Oftar
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MendozaArgentinaUnknown status
Grupo Láser Visión
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RosarioArgentinaUnknown status
Microcirugía Ocular S.A
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RosarioArgentinaUnknown status
Institut de l'oeil des Laurentides
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BoisbriandCanadaUnknown status
Retina Institute of Ottawa
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OttawaCanadaUnknown status
Toronto Retina Institute
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TorontoCanadaUnknown status
Faculty Hospital Ostrava
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OstravaCzechiaUnknown status
Faculty Hospital Kralovske Vinohrady
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PragueCzechiaUnknown status
General Teaching Hospital Prague
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PragueCzechiaUnknown status
AXON clinical
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PragueCzechiaUnknown status
Oftalvist Valencia
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BurjassotSpainUnknown status
Hospital Universitario Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital General de Catalunya
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Sant Cugat de VallesSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status
Bristol Eye Hospital
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BristolUnited KingdomUnknown status
Gloucestershire Hospitals NHS Foundation Trust
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GloucestershireUnited KingdomUnknown status
Royal Surrey County Hospital
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GuildfordUnited KingdomUnknown status
Moorfields Eye Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
Yeungnam University Medical Center
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DaeguSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Kim's Eye Hospital
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SeoulSouth KoreaUnknown status
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
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GliwicePolandUnknown status
Uniwersyteckie Centrum Kliniczne
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KatowicePolandUnknown status
Centrum Medyczne UNO-MED
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KrakowPolandUnknown status
SPSK nr 1 w Lublinie
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LublinPolandUnknown status
Centrum Diagnostyki i Mikrochirurgii Oka LENS
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OlsztynPolandUnknown status
LensClinic
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RybnikPolandUnknown status
Caminomed
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Tarnowskie GóryPolandUnknown status
Emanuelli Research and Development Center, LLC
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AreciboPuerto RicoUnknown status
Win Retina
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ArcadiaUnited StatesUnknown status
Texas Retina Associates
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ArlingtonUnited StatesUnknown status
Western Carolina Retinal Associate PA
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AshevilleUnited StatesUnknown status
Austin Clinical Research, LLC
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AustinUnited StatesUnknown status
Retina Consultants of Texas
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BellaireUnited StatesUnknown status
Meridian Clinical Research
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CincinnatiUnited StatesUnknown status
Rand Eye
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Deerfield BeachUnited StatesUnknown status
Erie Retinal Surgery
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ErieUnited StatesUnknown status
Verum Research, LLC
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EugeneUnited StatesUnknown status
National Ophthalmic Research Institute
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Fort MyersUnited StatesUnknown status
Cumberland Valley Retina PC
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HagerstownUnited StatesUnknown status
Eye Care Specialists, PC
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KingstonUnited StatesUnknown status
Charleston Neuroscience Institute
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LadsonUnited StatesUnknown status
Colorado Retina Associates, PC
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LakewoodUnited StatesUnknown status
Butchertown Clinical Trials
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LouisvilleUnited StatesUnknown status
Opthalmic Consultants of LI
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LynbrookUnited StatesUnknown status
Piedmont Eye Center
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LynchburgUnited StatesUnknown status
Valley Retina Institute P.A.
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McAllenUnited StatesUnknown status
Retina Consultants of Nashville
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NashvilleUnited StatesUnknown status
Wagner Macula & Retina Center
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NorfolkUnited StatesUnknown status
Florida Retina Institute
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OrlandoUnited StatesUnknown status
EyeHealth Northwest
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PortlandUnited StatesUnknown status
Retina Consultants San Diego
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PowayUnited StatesUnknown status
Black Hills Eye Institute
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Rapid CityUnited StatesUnknown status
Sierra Eye Associates
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RenoUnited StatesUnknown status
University of Rochester Flaum Eye Institute
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RochesterUnited StatesUnknown status
Retinal Consultants Med Group
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SacramentoUnited StatesUnknown status
Sewickley Eye Group
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SewickleyUnited StatesUnknown status
Deep Blue Retina PLLC
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SouthavenUnited StatesUnknown status
Retina Vitreous Associates of Florida
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St. PetersburgUnited StatesUnknown status
Retina Consultants of Texas
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The WoodlandsUnited StatesUnknown status
Bay Area Retina Associates
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Walnut CreekUnited StatesUnknown status
Emerson Clinical Research Institute LLC
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Washington D.C.United StatesUnknown status
Retina Specialists of Tampa
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Wesley ChapelUnited StatesUnknown status
Strategic Clinical Research Group, LLC
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Willow ParkUnited StatesUnknown status
Wake Forest Baptist Medical Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.