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
- Diseases
- Diabetic eye disease
- 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, 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
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Organización Médica de Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Oftalmologico Dr. Charles S.A. Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Oftalmos Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Buenos Aires Mácula Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| Centro Privado de Ojos Romagosa Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro de ojos Loria Coordinator of this site? Confirm its status | Lomas de Zamora | Argentina | Unknown status |
| Oftar Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Grupo Láser Visión Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Microcirugía Ocular S.A Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Institut de l'oeil des Laurentides Coordinator of this site? Confirm its status | Boisbriand | Canada | Unknown status |
| Retina Institute of Ottawa Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Toronto Retina Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Faculty Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Faculty Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| General Teaching Hospital Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| AXON clinical Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Oftalvist Valencia Coordinator of this site? Confirm its status | Burjassot | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat de Valles | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Bristol Eye Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Gloucestershire Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Gloucestershire | United Kingdom | Unknown status |
| Royal Surrey County Hospital Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Moorfields Eye Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kim's Eye Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA Coordinator of this site? Confirm its status | Gliwice | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Medyczne UNO-MED Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| SPSK nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| LensClinic Coordinator of this site? Confirm its status | Rybnik | Poland | Unknown status |
| Caminomed Coordinator of this site? Confirm its status | Tarnowskie Góry | Poland | Unknown status |
| Emanuelli Research and Development Center, LLC Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Win Retina Coordinator of this site? Confirm its status | Arcadia | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Western Carolina Retinal Associate PA Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Meridian Clinical Research Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rand Eye Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Erie Retinal Surgery Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Verum Research, LLC Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| National Ophthalmic Research Institute Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Cumberland Valley Retina PC Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Eye Care Specialists, PC Coordinator of this site? Confirm its status | Kingston | United States | Unknown status |
| Charleston Neuroscience Institute Coordinator of this site? Confirm its status | Ladson | United States | Unknown status |
| Colorado Retina Associates, PC Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Butchertown Clinical Trials Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Opthalmic Consultants of LI Coordinator of this site? Confirm its status | Lynbrook | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Valley Retina Institute P.A. Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Retina Consultants of Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Wagner Macula & Retina Center Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Florida Retina Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Retina Consultants San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Black Hills Eye Institute Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| University of Rochester Flaum Eye Institute Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Retinal Consultants Med Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sewickley Eye Group Coordinator of this site? Confirm its status | Sewickley | United States | Unknown status |
| Deep Blue Retina PLLC Coordinator of this site? Confirm its status | Southaven | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Emerson Clinical Research Institute LLC Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Retina Specialists of Tampa Coordinator of this site? Confirm its status | Wesley Chapel | United States | Unknown status |
| Strategic Clinical Research Group, LLC Coordinator of this site? Confirm its status | Willow Park | United States | Unknown status |
| Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.