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

Launched by GENENTECH, INC. · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RO7497372 for people with Diabetic Macular Edema (DME), a condition that can cause vision problems due to diabetes. The trial will look at how safe the treatment is and how well it works. It has two parts: the first part will test different doses of the treatment in participants to see how their bodies react to it, while the second part will focus on two specific doses that were found to be safe. Participants will receive the treatment through an injection in the eye and will be closely monitored for any side effects.

To be eligible for this trial, participants must have diabetes and specific eye-related issues caused by DME, such as thickening of the macula and reduced vision. They should also be able to provide a sample of fluid from their eye for testing. However, certain health conditions or recent surgeries may exclude someone from participating. If you or a loved one is interested, you can expect regular appointments for monitoring and testing throughout the study, with the goal of helping improve treatment options for DME.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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