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Evaluating a new treatment for diabetic macular edema

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema

Phase1; Phase2 Interventional Genentech, Inc. · NCT06850922

This study is testing a new treatment for diabetic macular edema to see if a combination of two medications works better than just one.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment546 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Drugs / interventionsranibizumab, faricimab
Locations55 sites (Phoenix, Arizona and 54 other locations)
Trial IDNCT06850922 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of RO7446603 in patients with diabetic macular edema (DME). It consists of two phases: Phase I assessed the safety of RO7446603 alone and in combination with other treatments, while Phase II will focus on the efficacy of RO7446603 combined with faricimab compared to faricimab alone. Participants will receive intravitreal injections of the study drug(s) to determine the best treatment approach for DME.

Who should consider this trial

Good fit: Ideal candidates include individuals with diabetes mellitus and significant macular thickening due to DME.

Not a fit: Patients with uncontrolled diabetes or those who have recently started anti-diabetic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from diabetic macular edema.

How similar studies have performed: Other studies have shown promise in treating diabetic macular edema with similar approaches, but this specific combination is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Phoenix, Arizona and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular Edema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.