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NCT05151744CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
187 (actual)
First submitted
8 Dec 2021
Start date
17 Dec 2021
Primary completion date
17 Apr 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05151744
EudraCT number
2021-004390-31

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 187
  • From 17 Dec 2021 to the primary completion date, 17 Apr 2024
  • 38 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, not your situation.

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 (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Organización Médica de Investigación
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Buenos AiresArgentinaUnknown status
Oftalmos
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Capital FederalArgentinaUnknown status
Centro Oftalmologico Dr. Charles S.A.
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Capital FederalArgentinaUnknown status
Buenos Aires Mácula
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Grupo Láser Visión
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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
Clínica Universitaria de Navarra
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MadridSpainUnknown status
Clinica Universitaria de Navarra
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PamplonaSpainUnknown status
Gloucestershire Hospitals NHS Foundation Trust
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GloucestershireUnited KingdomUnknown status
Royal Surrey County Hospital
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GuildfordUnited KingdomUnknown status
Kings College Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Hadassah MC
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JerusalemIsraelUnknown status
Rabin MC
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Petah TikvaIsraelUnknown status
Kaplan Medical Center
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RehovotIsraelUnknown status
Tel-Aviv Sourasky MC
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Tel AvivIsraelUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Yeungnam University Medical Center
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DaeguSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung 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
Centrum Medyczne UNO-MED
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KrakowPolandUnknown status
Centrum Diagnostyki i Mikrochirurgii Oka LENS
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OlsztynPolandUnknown 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
Retina Consultants of Texas
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BellaireUnited StatesUnknown status
Verum Research, LLC
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EugeneUnited StatesUnknown status
Cumberland Valley Retina Consultants
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HagerstownUnited StatesUnknown status
Florida Eye Associates
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MelbourneUnited StatesUnknown status
Deep Blue Retina PLLC
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SouthavenUnited StatesUnknown status
Retina Vitreous Associates of Florida
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TampaUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesUnknown status
Bay Area Retina Associates
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Walnut CreekUnited StatesUnknown status

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