Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Keywords

Diabetic Macular Edema, aflibercept, faricimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • The Retina Partners withdrawn
    Encino California 91436 United States
  • Macula Retina Vitreous Research Institute accepting new patients
    Torrance California 90503-3270 United States
  • Retina Consultants of Orange County accepting new patients
    Fullerton California 92835 United States
  • Retinal Consultants Medical Group accepting new patients
    Sacramento California 95825 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT06850922
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 546 study participants
Last Updated