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

Completed · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT06850922

Run by

Genentech, Inc.

People needed

388

Starts

2022-06-22

Expected to finish

2026-06-19

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) < 12%
• Macular thickening secondary to DME involving the center of the fovea > 325 microns
• Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters

You may not qualify if…

• Currently untreated DM or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
• Uncontrolled blood pressure (BP)
• Pregnancy or breastfeeding, or intention to become pregnant during the study
• For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants
• Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
• Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1
• Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
• Proliferative diabetic retinopathy (PDR) in the study eye
• Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye Other protocol-specified inclusion/exclusion criteria may apply

Where it is running

• 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
• University of Colorado - Eye Center - PPDS — Aurora, Colorado, United States
• Retina Consultants of Southern Colorado PC — Colorado Springs, Colorado, United States
• Retina Specialists of Colorado — Denver, Colorado, United States
• Advanced Vision Research Institute — Longmont, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Retina Institute — Jacksonville, Florida, United States
• Retina Associates of Florida;Retina Associates of Florida — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States
• Illinois Eye and Ear Infirmary — Chicago, Illinois, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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