Hoffman-LaRoche YOSEMITE for Diabetic Macular Edema Study

Active Clinical Trials // Jan 28 2019

Protocol No.: GR40349

Sponsor: F. Hoffmann-La Roche Ltd

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 (YOSEMITE)

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).

Current Primary Outcome:

Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year Time Frame: Baseline (Day 1) and 1 year

Estimated Enrollment: 900

Ages: 18 years and older

Intervention

  • Drug: Aflibercept

Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Other Name: Eylea

  • 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.

Other Name: RG7716

  • 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 clinic visits to maintain masking among treatment arms.

Study Arms

  • Experimental: A: RO6867461 Q8W

Interventions:

    • Drug: RO6867461
    • Drug: Sham Procedure
  • Experimental: B: RO6867461 As Specified in Protocol

Interventions:

    • Drug: RO6867461
    • Drug: Sham Procedure
  • Active Comparator: C: Aflibercept Q8W

Interventions:

    • Drug: Aflibercept
    • Drug: Sham Procedure

Eligibility 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 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 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 the past 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

For more information please contact Chris Smith 608 263-7169