A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE)
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ClinicalTrials.gov Identifier: NCT03622593 |
Recruitment Status :
Enrolling by invitation
First Posted : August 9, 2018
Last Update Posted : December 9, 2020
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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).
The global enrollment phase has closed, but participants are still being recruited only at sites in China.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: Aflibercept Drug: Faricimab Drug: Sham Procedure | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 951 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | October 9, 2018 |
Actual Primary Completion Date : | October 19, 2020 |
Estimated Study Completion Date : | July 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: A: Faricimab Q8W |
Drug: Faricimab
Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
Other Names:
Drug: 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 will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms. |
Experimental: B: Faricimab As Specified in Protocol |
Drug: Faricimab
Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
Other Names:
Drug: 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 will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms. |
Active Comparator: C: Aflibercept Q8W |
Drug: Aflibercept
Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Other Name: Eylea Drug: 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 will be administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms. |
- Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year [ Time Frame: Baseline (Day 1) and 1 year ]As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
- Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year [ Time Frame: Baseline and 1 year ]
- Change From Baseline in BCVA Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year [ Time Frame: 1 year ]
- Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years [ Time Frame: 2 years ]
- Change From Baseline in Central Subfield Thickness Over Time [ Time Frame: From Baseline up to 2 years ]
- Change From Baseline in Central Subfield Thickness at 1 Year [ Time Frame: Baseline and 1 year ]
- Percentage of Participants with Absence of DME Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
- Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time [ Time Frame: From Baseline up to 2 years ]
- Percentage of Participants with At Least One Ocular Adverse Event [ Time Frame: Up to 2 years ]
- Percentage of Participants with At Least One Non-Ocular Adverse Event [ Time Frame: Up to 2 years ]
- Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
- Percentage of Participants with Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622593

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT03622593 |
Other Study ID Numbers: |
GR40398 2017-005105-12 ( EudraCT Number ) |
First Posted: | August 9, 2018 Key Record Dates |
Last Update Posted: | December 9, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Edema Edema Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |