A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

CompletadoFase 3ClinicalTrials.gov

ID: NCT03622593Tipo: INTERVENTIONALInicio: 9 de oct de 2018Fin estimado: 31 de may de 2023

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
Decreased visual acuity attributable primarily to DME
Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
Ability and willingness to undertake all scheduled visits and assessments
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Criterios de exclusión

Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
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
Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
Prior administration of IVT faricimab in either eye
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

Aflibercept

Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

drug

Faricimab

Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.

procedure

Sham Procedure

The 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. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

Fundacion Zambrano

CABA, Argentina

Oftalmos

Capital Federal, Argentina

Oftar

Mendoza, Argentina

Centro Oftalmólogos Especialistas

Rosario, Argentina

Grupo Laser Vision

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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