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

Description

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.

Conditions

Diabetic Macular Edema

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Study Overview

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Study Details

Study overview

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.

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

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
Intervention / Treatment

-

Contacts and Locations

Phoenix

Barnet Dulaney Perkins Eye Center, Phoenix, Arizona, United States, 85016

Phoenix

Associated Retinal Consultants PC, Phoenix, Arizona, United States, 85020

Phoenix

Retinal Consultants of Arizona, Phoenix, Arizona, United States, 85053

Encino

The Retina Partners, Encino, California, United States, 91436

Sacramento

Retinal Consultants Medical Group, Sacramento, California, United States, 95825

Clearwater

Blue Ocean Clinical Research, Clearwater, Florida, United States, 33761-2046

Fort Myers

National Ophthalmic Research Institute, Fort Myers, Florida, United States, 33912

Marietta

Georgia Retina PC, Marietta, Georgia, United States, 30060

Lemont

University Retina and Macula Associates, PC, Lemont, Illinois, United States, 60439

Indianapolis

Raj K. Maturi, MD PC, Indianapolis, Indiana, United States, 46290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-04-30