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

CompletadoFase 2ClinicalTrials.gov

ID: NCT05151744Tipo: INTERVENTIONALInicio: 17 de dic de 2021Fin estimado: 1 de oct de 2024

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Vamikibart

Vamikibart will be administered by IVT injection in the study eye.

drug

Ranibizumab

Ranibizumab will be administered by IVT injection in the study eye.

other

Sham Procedure

Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.

Ubicaciones

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

Patrocinadores

PrincipalHoffmann-La Roche

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