A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT05151744
- Run by
- Hoffmann-La Roche
- People needed
- 187
- Starts
- 2021-12-17
- Expected to finish
- 2024-10-01
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Hemoglobin A1c (HbA1c) of greater than (>) 12%
- 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
- 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
- Any proliferative diabetic retinopathy
- 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
- Other protocol-specified inclusion/exclusion criteria may apply
Where it is running
- Win Retina — Arcadia, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Bay Area Retina Associates — Walnut Creek, California, United States
- Florida Eye Associates — Melbourne, Florida, United States
- Retina Vitreous Associates of Florida — Tampa, Florida, United States
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
- Deep Blue Retina PLLC — Southaven, Mississippi, United States
- Verum Research LLC — Eugene, Oregon, United States
- Texas Retina Associates — Arlington, Texas, United States
- Retina Consultants of Texas — Bellaire, Texas, United States
- Organizacion Medica de Investigacion — Buenos Aires, Argentina
- Centro Oftalmológico Dr. Charles S.A. — Capital Federal, Argentina
- Oftalmos — Capital Federal, Argentina
- Buenos Aires Mácula — Ciudad Autonoma Buenos Aires, Argentina
- Grupo Laser Vision — Rosario, Argentina
- Retina Institute of Ottawa — Ottawa, Ontario, Canada
- Toronto Retina Institute — Toronto, Ontario, Canada
- Institut De L'Oeil Des Laurentides — Boisbriand, Quebec, Canada
- Rambam Medical Center — Haifa, Israel
- Hadassah MC — Jerusalem, Israel
- Rabin MC — Petah Tikva, Israel
- Kaplan Medical Center — Rehovot, Israel
- Tel Aviv Sourasky MC — Tel Aviv, Israel
- Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA — Gliwice, Poland
- Centrum Medyczne UNO-MED — Krakow, Poland
Full record on ClinicalTrials.gov
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