A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME) (NCT07425522)
A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants - Peoria - DocTrials - PPDS — Peoria, 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 (12 Sites)
- Associated Retina Consultants - Peoria - DocTrials - PPDS — Peoria, Arizona
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS — Walnut Creek, California
- Retina Vitreous Associates of Florida — St. Petersburg, Florida
- Wilmer Eye Institute — Baltimore, Maryland
- Erie Retina Research, LLC - 300 State St — Erie, Pennsylvania
- Wills Eye Hospital — Philadelphia, Pennsylvania
- Charles Retina Institute — Germantown, Tennessee
- Retina Research Institute of Texas — Abilene, Texas
- Austin Clinical Research, LLC — Austin, Texas
- Retina Consultants of Texas Westover Hills Retina Center — San Antonio, Texas
- Piedmont Eye Center — Lynchburg, Virginia
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME) — Mesa, Arizona
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.