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

Running, not enrolling · Phase 1

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT06847854

Run by

Genentech, Inc.

People needed

151

Starts

2022-12-08

Expected to finish

2027-01-12

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
• Participant consents to AH collection
• Collection of > 90 microlitres (µL) AH (at each visit required per schedule of activities [SoA]) if deemed feasible and safe by the Investigator.
• Macular thickening secondary to DME involving the center of the fovea with CST >= 325 µm at screening
• Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
• Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
• Diagnosis of non-proliferative DR
• Treatment-naive and Pre-treated participants after washout

You may not qualify if…

• Any major illness or major surgical procedure ≤ 4 weeks before Day 1
• Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
• Active cancer ≤ 1 year prior to Day 1
• Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
• HbA1c ≥ 12% at screening
• Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
• History of vitreoretinal surgery/pars plana vitrectomy
• Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
• History of any glaucoma surgery including laser glaucoma procedures
• Uncontrolled glaucoma
• Any active intra- or periocular infection on Day 1
• Any active or history of Intraocular inflammation
• Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
• Any proliferative DR

Where it is running

• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States
• Retinal Consultants of AZ, Ltd — Peoria, Arizona, United States
• Associated Retina Consultants — Phoenix, Arizona, United States
• Arkansas Retina Research — Little Rock, Arkansas, United States
• Global Research Management — Glendale, California, United States
• Retinal Consultants Medical Group — Modesto, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Medeye Associates — South Miami, Florida, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Retina Specialists of Tampa — Wesley Chapel, Florida, United States
• Center for Retina and Macula Disease — Winter Haven, Florida, United States
• Cumberland Valley Retina PC — Hagerstown, Maryland, United States
• Retina Associates of Michigan — Grand Blanc, Michigan, United States
• Foundation for Vision Research — Grand Rapids, Michigan, United States
• Retina Consultants Minnesota — Saint Louis Park, Minnesota, United States
• Mississippi Retina Associates — Madison, Mississippi, United States
• The Retina Institute — St Louis, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Ross Eye Institute — Buffalo, New York, United States
• Retina Associates of NY — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Verum Research LLC — Eugene, Oregon, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Erie Retinal Surgery — Erie, Pennsylvania, United States

Full record on ClinicalTrials.gov

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