A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
Condition: Diabetic Macular Edema · Sponsor: Genentech, Inc.
About this study
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (77)
| Arizona Retina and Vitreous Consultants | Phoenix, Arizona, United States | — |
| Associated Retinal Consultants PC | Phoenix, Arizona, United States | — |
| Retinal Research Institute, LLC | Phoenix, Arizona, United States | — |
| Retina Partners of Northwest Arkansas, PLLC | Springdale, Arkansas, United States | — |
| Retinal Diagnostic Center | Campbell, California, United States | — |
| Retina Consultants of Orange County | Fullerton, California, United States | — |
| Retinal Consultants Medical Group | Modesto, California, United States | — |
| Northern California Retina-Vitreous Associates | Mountain View, California, United States | — |
| Retinal Consultants Medical Group | Sacramento, California, United States | — |
| University of California San Francisco | San Francisco, California, United States | — |
| Macula Retina Vitreous Research Institute | Torrance, California, United States | — |
| Bay Area Retina Associates;Study Department | Walnut Creek, California, United States | — |
+ 65 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06850922