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A clinical trial to compare faricimab with aflibercept in people with diabetic macular edema. (RHINE)
A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema
Eye Disorder Diabetic Macular Edema
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT03622593, GR40398, 2017-005105-12
Condition
Diabetic Macular Edema
Official Title
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)
Study Summary
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).
Eligibility Criteria
All
≥ 18 Years
No
Inclusion Criteria
- 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
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
- Decreased visual acuity attributable primarily to DME
- 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
Exclusion Criteria
- 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
- Other protocol-specified inclusion/exclusion criteria may apply
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com