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A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema (RHINE)

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ClinicalTrials.gov Identifier: NCT03622593
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aflibercept Drug: RO6867461 Drug: Sham Procedure Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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 RO6867461 in Patients With Diabetic Macular Edema (RHINE)
Estimated Study Start Date : September 21, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : June 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: A: RO6867461 Q8W Drug: RO6867461
RO6867461 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.

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: RO6867461 As Specified in Protocol Drug: RO6867461
RO6867461 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.

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).

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Change From Baseline in BCVA Over Time [ Time Frame: From Baseline up to 2 years ]
  3. Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  4. Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  5. Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  6. Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  7. Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  8. Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  9. Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  10. Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  11. 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 ]
  12. 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 ]
  13. Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 2 years ]
  14. Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 2 years ]
  15. Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 2 years ]
  16. Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time [ Time Frame: Up to 2 years ]
  17. Percentage of Participants in the RO6867461 As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year [ Time Frame: 1 year ]
  18. Percentage of Participants in the RO6867461 As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years [ Time Frame: 2 years ]
  19. Change From Baseline in Central Subfield Thickness (CST) Over Time [ Time Frame: From Baseline up to 2 years ]
  20. Percentage of Participants with Absence of DME Over Time [ Time Frame: Up to 2 years ]
  21. Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  22. Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  23. Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  24. 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 ]
  25. Percentage of Participants With Ocular Adverse Events [ Time Frame: Up to 2 years ]
  26. Percentage of Participants With Non-Ocular Adverse Events [ Time Frame: Up to 2 years ]
  27. Plasma Concentration of RO6867461 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) ]
  28. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to (≤) 10%
  • 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 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 anti-diabetic medication or insulin 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 RO6867461 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

Information from the National Library of Medicine

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


Contacts
Contact: Reference Study ID Number: GR40398 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03622593     History of Changes
Other Study ID Numbers: GR40398
2017-005105-12 ( EudraCT Number )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases