Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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).

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)

Keywords

Diabetic Macular Edema Edema Macular Edema Aflibercept RO6867461 Sham Procedure C: Aflibercept Q8W

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Univ of California, San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Retina Consultants of Orange County not yet accepting patients
    Fullerton California 92835 United States
  • South Coast Retina Center not yet accepting patients
    Los Angeles California 90033 United States
  • USC Roski Eye Institute not yet accepting patients
    Los Angeles California 90333 United States
  • Doheny Eye Institute not yet accepting patients
    Pasadena California 91105 United States
  • Retina-Vitreous Associates Medical Group not yet accepting patients
    Beverly Hills California 90211 United States
  • The Retina Partners not yet accepting patients
    Encino California 91436 United States
  • California Retina Consultants not yet accepting patients
    Santa Barbara California 93103 United States
  • California Retina Consultants not yet accepting patients
    Bakersfield California 93309 United States
  • Retina Consultants of Nevada not yet accepting patients
    Las Vegas Nevada 89123 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03622593
Phase
Phase 3
Study Type
Interventional
Last Updated
September 5, 2018