A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated (NCT07553429)
A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I/IIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans. This study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections. Participants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants, Ltd. — Phoenix, 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 (30 Sites)
Showing the first 25 of 30 sites.
- Associated Retina Consultants, Ltd. — Phoenix, Arizona
- Research Network Arizona — Scottsdale, Arizona
- Win Retina — Arcadia, California
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Global Research Management — Glendale, California
- Retina Associates of Southern California — Huntington Beach, California
- California Retina Consultants-Oxnard-70187 — Oxnard, California
- Retinal Consultants Medical Group — Sacramento, California
- Bay Area Retina Associates - Walnut Creek — Walnut Creek, California
- Retina Group of New England, PC — Waterford, Connecticut
- Retina Group of Florida - Fort Myers Retina Center — Fort Myers, Florida
- Florida Retina Consultants — Lakeland, Florida
- East Florida Eye Institute — Stuart, Florida
- Florida Retina Institute Wildwood — Wildwood, Florida
- Ophthalmic Consultants of Long Island — Oceanside, New York
- North Carolina Retina Associates — Wake Forest, North Carolina
- Red River Research Partners, LLC — Fargo, North Dakota
- Cleveland Clinic — Cleveland, Ohio
- Verum Research, LLC — Eugene, Oregon
- EyeHealth Northwest — Portland, Oregon
- Tennessee Retina — Nashville, Tennessee
- Austin Clinical Research, LLC — Austin, Texas
- Retina Consultants of Texas-Bellaire-67493 — Bellaire, Texas
- Valley Retina Institute, PA — McAllen, Texas
- Medical Center Ophthalmology Associates — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.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.