NCT06847854Active, not recruitingPhase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
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)
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 151 (actual)
- First submitted
- 21 Feb 2025
- Start date
- 8 Dec 2022
- Primary completion date
- 16 Nov 2026
- Lead sponsor
- Genentech, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT06847854
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 151
- From 8 Dec 2022 to the primary completion date, 16 Nov 2026
- 38 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
- Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
- Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
Other illness
- History of vitreoretinal surgery/pars plana vitrectomy
- History of any glaucoma surgery including laser glaucoma procedures
- Any active intra- or periocular infection on Day 1
- Any active or history of Intraocular inflammation
Lab values
- HbA1c ≥ 12% at screening
Other
- Uncontrolled glaucoma
- Any proliferative DR
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emanuelli Research and Development Center, LLC Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Ross Eye Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Erie Retinal Surgery Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Verum Research, LLC Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Retina Group of Washington Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Emerson Clinical Research Institute Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Global Research Management Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Retina Associates of Michigan Coordinator of this site? Confirm its status | Grand Blanc | United States | Unknown status |
| Foundation for Vision Research Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Cumberland Valley Retina PC Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Arkansas Retina Research Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Mississippi Retina Associates Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Florida Eye Associates Coordinator of this site? Confirm its status | Melbourne | United States | Unknown status |
| Barnet Dulaney Perkins Eye Center Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Carolina Eyecare Physicians Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
| Retina Associates of NY Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Wagner Kapoor Institute Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Retinal Consultants of AZ, Ltd Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Retina Consultants Minnesota Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
| Brown Retina Institute Coordinator of this site? Confirm its status | Schertz | United States | Unknown status |
| MedEye Associates Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
| Spokane Eye Clinic Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| The Retina Institute Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| East Florida Eye Institute Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Retina Specialists of Tampa Coordinator of this site? Confirm its status | Wesley Chapel | United States | Unknown status |
| Salt Lake Retina Coordinator of this site? Confirm its status | West Jordan | United States | Unknown status |
| Center for Retina and Macula Disease Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.