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
- Diseases
- Diabetic eye disease
- 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
Sites (38)
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 |
| Oftalmos Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| Centro Oftalmologico Dr. Charles S.A. 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 |
| Grupo Láser Visión 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 |
| Clínica Universitaria de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Universitaria de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | 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 |
| Kings College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah MC Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin MC Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Tel-Aviv Sourasky MC Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung 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 |
| Centrum Medyczne UNO-MED Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS Coordinator of this site? Confirm its status | Olsztyn | 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 |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Verum Research, LLC Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Florida Eye Associates Coordinator of this site? Confirm its status | Melbourne | 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 | Tampa | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.