Investigating a new treatment for diabetic macular edema
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)
This study is testing a new treatment called RO7497372 to see if it is safe and effective for people with diabetic macular edema.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 14 sites (Peoria, Arizona and 13 other locations) |
| Trial ID | NCT06847854 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with type 1 or type 2 diabetes who have diabetic macular edema affecting the center of the fovea.
Not a fit: Patients with recent major illnesses, surgeries, or active cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients suffering from diabetic macular edema.
How similar studies have performed: Other studies have shown promise in treating diabetic macular edema with similar pharmacological approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Peoria, Arizona and 13 other locations
- 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)
- Bay Area Retina Associates — Walnut Creek, California, United States (Active_not_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)
- Ross Eye Institute — Buffalo, New York, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Erie Retinal Surgery — Erie, Pennsylvania, United States (Completed)
- Austin Clinical Research LLC — Austin, Texas, United States (Active_not_recruiting)
- Retina Consultants of Texas — The Woodlands, Texas, United States (Recruiting)
- Spokane Eye Clinical Research — Spokane, Washington, United States (Recruiting)
- Emanuelli Research and Development Center — Arecibo, Puerto Rico (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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.