ACTIVE_NOT_RECRUITING

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

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 will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.

Official Title

A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)

Quick Facts

Study Start:2022-12-08
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06847854

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. * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
  2. * Participant consents to AH collection
  3. * Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) if deemed feasible and safe by the Investigator.
  4. * Macular thickening secondary to DME involving the center of the fovea with CST \>= 325 µm at screening
  5. * Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
  6. * Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
  7. * Diagnosis of non-proliferative DR
  8. * Treatment-naive and Pre-treated participants after washout
  1. * Any major illness or major surgical procedure ≤ 4 weeks before Day 1
  2. * Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
  3. * Active cancer ≤ 1 year prior to Day 1
  4. * Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
  5. * HbA1c ≥ 12% at screening
  6. * Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
  7. * History of vitreoretinal surgery/pars plana vitrectomy
  8. * Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
  9. * History of any glaucoma surgery including laser glaucoma procedures
  10. * Uncontrolled glaucoma
  11. * Any active intra- or periocular infection on Day 1
  12. * Any active or history of Intraocular inflammation
  13. * Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
  14. * Any proliferative DR

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206
United States
Retinal Consultants of AZ, Ltd
Peoria, Arizona, 85381
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Arkansas Retina Research
Little Rock, Arkansas, 72205
United States
Global Research Management
Glendale, California, 91204
United States
Retinal Consultants Medical Group
Modesto, California, 95356
United States
Bay Area Retina Associates
Walnut Creek, California, 94598
United States
Florida Eye Associates
Melbourne, Florida, 32901
United States
Medeye Associates
Miami, Florida, 33143
United States
East Florida Eye Institute
Stuart, Florida, 34994
United States
Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
United States
Center for Retina and Macula Disease
Winter Haven, Florida, 33880
United States
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740
United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439-8301
United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546
United States
Retina Consultants Minnesota
Saint Louis Park, Minnesota, 55416
United States
Mississippi Retina Associates
Madison, Mississippi, 39202
United States
The Retina Institute
St Louis, Missouri, 63128
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Ross Eye Institute
Buffalo, New York, 14209-2102
United States
Retina Associates of NY
New York, New York, 10075
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
United States
Verum Research LLC
Eugene, Oregon, 97401
United States
EyeHealth Northwest
Portland, Oregon, 97225
United States
Erie Retinal Surgery
Erie, Pennsylvania, 16507
United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Austin Clinical Research LLC
Austin, Texas, 78750
United States
Brown Retina Institute
Schertz, Texas, 78154
United States
Retina Consultants of Texas
The Woodlands, Texas, 78240
United States
Salt Lake Retina
West Jordan, Utah, 84088
United States
Retina Group of Washington
Fairfax, Virginia, 20815
United States
Emerson Clinical Research Institute
Falls Church, Virginia, 78503
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Wagner Kapoor Institute
Norfolk, Virginia, 23502
United States
Spokane Eye Clinical Research
Spokane, Washington, 99204-2509
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 Date2022-12-08
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-12-08
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Macular Edema