Investigating a new treatment for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of RO7497372 in patients with diabetic macular edema (DME). It consists of two parts: the first part tests multiple ascending doses of RO7497372 administered via unilateral intravitreal injection, focusing on safety, tolerability, and pharmacokinetics. The second part assesses two identified safe dose strengths of RO7497372 to further characterize its pharmacodynamics and safety profile. The study aims to provide critical data on the drug's effects in the target population.

Why it matters

Who can join: the full rules

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

Where it's running

• Retinal Consultants of AZ, Ltd
  Peoria, Arizona, United States Recruiting
• Associated Retina Consultants
  Phoenix, Arizona, United States Recruiting
• Retinal Consultants Medical Group
  Modesto, California, United States Recruiting
• Florida Eye Associates
  Melbourne, Florida, United States Recruiting
• Cumberland Valley Retina PC
  Hagerstown, Maryland, United States Recruiting
• Retina Associates of Michigan
  Grand Blanc, Michigan, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: BP44175 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.