RHINE
E871107
RHINE is a pivotal phase III clinical trial evaluating faricimab for the treatment of diabetic macular edema.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
clinical trial
ⓘ
phase III clinical trial ⓘ randomized controlled trial ⓘ |
| comparesWith | aflibercept NERFINISHED ⓘ |
| developsDrugFor |
Genentech
NERFINISHED
ⓘ
Roche NERFINISHED ⓘ |
| enrollsPatientsWith | center-involved diabetic macular edema ⓘ |
| evaluates | faricimab NERFINISHED ⓘ |
| focusesOnOutcome |
maintenance of visual acuity gains
ⓘ
reduction of retinal edema ⓘ |
| hasAllocation | randomized ⓘ |
| hasConditionStudied | diabetic macular edema GENERATED ⓘ |
| hasControlArm | aflibercept 2 mg every 8 weeks after loading GENERATED ⓘ |
| hasExperimentalArm |
faricimab fixed dosing
ⓘ
faricimab personalized treatment interval ⓘ |
| hasGeographicScope | international ⓘ |
| hasIntervention | faricimab NERFINISHED ⓘ |
| hasMasking | double-masked ⓘ |
| hasModality | biologic therapy ⓘ |
| hasOutcome |
demonstrated extended dosing intervals for faricimab in many patients
ⓘ
met primary endpoint of non-inferiority vs aflibercept in visual acuity gains ⓘ |
| hasPhase | phase III ⓘ |
| hasPrimaryEndpoint |
change in best-corrected visual acuity
ⓘ
non-inferiority to aflibercept in visual acuity gains ⓘ |
| hasRouteOfAdministration | intravitreal injection ⓘ |
| hasSecondaryEndpoint |
anatomical retinal outcomes
ⓘ
safety and tolerability ⓘ treatment durability ⓘ |
| hasStudyDesign |
active-controlled
ⓘ
double-masked ⓘ multicenter ⓘ randomized ⓘ |
| hasStudyType | interventional ⓘ |
| hasTherapeuticArea | ophthalmology ⓘ |
| investigatesIndication | diabetic macular edema ⓘ |
| isPartOfProgram | faricimab DME clinical development program ⓘ |
| isPivotalFor | regulatory approval of faricimab for diabetic macular edema ⓘ |
| relatedTrial | YOSEMITE NERFINISHED ⓘ |
| sponsors |
Genentech
NERFINISHED
ⓘ
Roche NERFINISHED ⓘ |
| studiesDrug | faricimab NERFINISHED ⓘ |
| supportsIndication | faricimab for treatment of diabetic macular edema GENERATED ⓘ |
| targetsPopulation | adults with diabetic macular edema ⓘ |
| therapeuticClassStudied | bispecific antibody targeting Ang-2 and VEGF-A ⓘ |
| trialPhase | phase III ⓘ |
| usesDosingRegimen |
fixed dosing arm
ⓘ
personalized treatment interval ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.