RECRUITING

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.

Official Title

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema

Quick Facts

Study Start:2022-06-22
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06850922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12%
  2. * Macular thickening secondary to DME involving the center of the fovea \> 325 microns
  3. * Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters
  1. * Currently untreated DM or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
  2. * Uncontrolled blood pressure (BP)
  3. * Pregnancy or breastfeeding, or intention to become pregnant during the study
  4. * For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants
  5. * Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
  6. * Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1
  7. * Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
  8. * Proliferative diabetic retinopathy (PDR) in the study eye
  9. * Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye Other protocol-specified inclusion/exclusion criteria may apply

Contacts and Locations

Study Contact

Reference Study ID Number: GR43828 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
United States
Associated Retinal Consultants PC
Phoenix, Arizona, 85020
United States
Retinal Consultants of Arizona
Phoenix, Arizona, 85053
United States
The Retina Partners
Encino, California, 91436
United States
Retinal Consultants Medical Group
Sacramento, California, 95825
United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761-2046
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
Georgia Retina PC
Marietta, Georgia, 30060
United States
University Retina and Macula Associates, PC
Lemont, Illinois, 60439
United States
Raj K. Maturi, MD PC
Indianapolis, Indiana, 46290
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
Cascade Medical Research Institute LLC
Springfield, Oregon, 97477
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169-2429
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Austin Retina Associates
Austin, Texas, 78705
United States
Austin Clinical Research LLC
Austin, Texas, 78750
United States
Retina & Vitreous of Texas
Bellaire, Texas, 77401
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Valley Retina Institute P.A.
McAllen, Texas, 78503
United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, 78240
United States
Brown Retina Institute
San Antonio, Texas, 78251-4551
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
United States
Wagner Kapoor Institute
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-22
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-06-22
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Macular Edema