A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME) (NCT06847854)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barnet Dulaney Perkins Eye Center — Mesa, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (38 Sites)
Showing the first 25 of 38 sites.
- Barnet Dulaney Perkins Eye Center — Mesa, Arizona
- Retinal Consultants of AZ, Ltd — Peoria, Arizona
- Associated Retina Consultants — Phoenix, Arizona
- Arkansas Retina Research — Little Rock, Arkansas
- Global Research Management — Glendale, California
- Retinal Consultants Medical Group — Modesto, California
- Bay Area Retina Associates — Walnut Creek, California
- Florida Eye Associates — Melbourne, Florida
- Medeye Associates — South Miami, Florida
- East Florida Eye Institute — Stuart, Florida
- Retina Specialists of Tampa — Wesley Chapel, Florida
- Center for Retina and Macula Disease — Winter Haven, Florida
- Cumberland Valley Retina PC — Hagerstown, Maryland
- Retina Associates of Michigan — Grand Blanc, Michigan
- Foundation for Vision Research — Grand Rapids, Michigan
- Retina Consultants Minnesota — Saint Louis Park, Minnesota
- Mississippi Retina Associates — Madison, Mississippi
- The Retina Institute — St Louis, Missouri
- Sierra Eye Associates — Reno, Nevada
- Ross Eye Institute — Buffalo, New York
- Retina Associates of NY — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Verum Research LLC — Eugene, Oregon
- EyeHealth Northwest — Portland, Oregon
- Erie Retinal Surgery — Erie, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Macular Edema
- Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT) — Beverly Hills, California
- 4D-150 in Patients With Diabetic Macular Edema — Hagerstown, Maryland
- Mean Visual Acuity Changes Following Five Injections of Aflibercept — Hamilton, Ontario
- A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema — Phoenix, Arizona
- A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME — Mesa, Arizona
Explore by condition: All Diabetic Macular Edema clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.