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 (THAMES)

June 22, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital - North Campus
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300384
        • Tianjin Medical University Eye Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Eye Hospital,WMU(Zhejiang Eye Hospital)
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research and Development Center LLC
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute, LLC
      • Phoenix, Arizona, United States, 85020-5917
        • Arizona Retina and Vitreous Consultants
      • Phoenix, Arizona, United States, 85020
        • Associated Retinal Consultants PC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Retina Partners of Northwest Arkansas, PLLC
    • California
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Modesto, California, United States, 95356-9412
        • Retinal Consultants Medical Group
      • Mountain View, California, United States, 94040
        • Northern California Retina-Vitreous Associates
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
      • San Francisco, California, United States, 94158
        • University of California San Francisco
      • Torrance, California, United States, 90503-3270
        • Macula Retina Vitreous Research Institute
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates;Study Department
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • University of Colorado - Eye Center - PPDS
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado PC
      • Denver, Colorado, United States, 80222
        • Retina Specialists of Colorado
      • Longmont, Colorado, United States, 80503-6499
        • Advanced Vision Research Institute
    • Connecticut
      • Waterford, Connecticut, United States, 06385-1215
        • Retina Group of New England
    • Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Jacksonville, Florida, United States, 32216-6347
        • Florida Retina Institute
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida;Retina Associates of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909-6440
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Illinois Eye and Ear Infirmary
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Raj K. Maturi, MD PC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Waldorf, Maryland, United States, 20602
        • Chesapeake Retina Centers - Waldorf
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants - Royal Oak
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Retina Consultants Minnesota
    • New York
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants;Opthalmology
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of CNY PC
      • Lynbrook, New York, United States, 11563
        • Opthalmic Consultants of LI
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
      • Cary, North Carolina, United States, 27511
        • North Carolina Retina Associates
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Hickory, North Carolina, United States, 28602
        • Graystone Eye-Hickory
      • Wake Forest, North Carolina, United States, 27587-3803
        • North Carolina (NC) Retina Associates - Wake Forest Office
      • Winston-Salem, North Carolina, United States, 27103-6970
        • Piedmont Retina Specialists
    • Ohio
      • Blue Ash, Ohio, United States, 45242-5537
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44016
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43212
        • Ohio State Eye and Ear Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultants
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Cascade Medical Research Institute LLC
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Erie Retina Research
      • Philadelphia, Pennsylvania, United States, 19107-5109
        • Wills Eye Hospital
      • Sewickley, Pennsylvania, United States, 15143
        • Sewickely Eye Group
    • South Carolina
      • West Columbia, South Carolina, United States, 29169-2429
        • Palmetto Retina Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research LLC
      • Bellaire, Texas, United States, 77401
        • Retina & Vitreous of Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • McAllen, Texas, United States, 78550-9207
        • Valley Retina Institute P.A.
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas - San Antonio
      • San Antonio, Texas, United States, 78251-4551
        • Brown Retina Institute
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah, PLLC;Clinical Research
    • Virginia
      • Lynchburg, Virginia, United States, 24502-4271
        • Piedmont Eye Center
      • Norfolk, Virginia, United States, 23502
        • Wagner Kapoor Institute
      • Richmond, Virginia, United States, 23230
        • Virginia Eye Institute - Richmond - 7301 Forest Ave
      • Richmond, Virginia, United States, 23235-1962
        • Retina Institute of Virginia
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinical Research

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Single Ascending Dose (SAD) Stage
Participants received a single dose of RO7446603 at five different dose levels as IVT injection on Day 1.
Drug: RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Experimental: Part 2: Multiple Dose (MD) Monotherapy Stage
Participants received four different dose levels of RO7446603 (two doses at each planned dose level) as IVT injection, every 8 weeks (Q8W).
Drug: RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Experimental: Part 3: MD Co-administration With Aflibercept Stage
Participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W along with four doses of aflibercept IVT injections, every 4 weeks (Q4W).
Drug: RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Drug: Aflibercept
Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
Experimental: Part 4: MD Co-administration With Faricimab Stage
Participants received a single dose of faricimab followed by a 4-week enrichment screening period. Eligible participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W, along with three doses of faricimab (co-administered with RO7446603 or alone) as IVT injection, Q4W.
Drug: RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Drug: Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
Other Names:
  • Vabysmo
Experimental: Part 5: MD Co-mixed With Faricimab Stage
Participants will receive two different dose levels of RO7446603 (co-mixed with faricimab or faricimab alone) as IVT injection, Q4W for the first six doses followed by Q8W for four doses.
Drug: RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Drug: Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
Other Names:
  • Vabysmo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parts 1-5: Percentage of Participants With Adverse Events (AEs)
Time Frame: From study start through end of study (Up to approximately 58 months)
From study start through end of study (Up to approximately 58 months)
Parts 1-5: Percentage of Participants With Ocular AEs
Time Frame: From study start through end of study (Up to approximately 58 months)
From study start through end of study (Up to approximately 58 months)
Part 1: Change in Best Corrected Visual Acuity (BCVA) Over Time
Time Frame: From Baseline up to Week 16
BCVA will be measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 16
Parts 2-4: Change in BCVA Over Time
Time Frame: From Baseline up to Week 28
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 28
Part 5: Change From Baseline in BCVA Averaged Over Weeks 52 and 56
Time Frame: From Baseline up to Week 56
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 56

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 5: Proportion of Participants Gaining ≥ 15 Letters in BCVA From Baseline Averaged Over Weeks 52 and 56
Time Frame: From Baseline up to Week 56
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 56
Part 5: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Time Frame: From Baseline up to Week 56
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 56
Part 5: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Time Frame: From Baseline up to Week 56
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 56
Part 5: Change From Baseline in BCVA Score Over Time
Time Frame: From Baseline up to Week 56
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
From Baseline up to Week 56
Parts 1-4: Serum Concentration of RO7446603 Total Fab
Time Frame: Part 1: From Baseline up to Week 16; Parts 2-4: From Baseline up to Week 28
Part 1: From Baseline up to Week 16; Parts 2-4: From Baseline up to Week 28
Parts 1-5: Aqueous Humor Concentration of RO7446603 Measured as Total Fab
Time Frame: From study start through end of study (Up to approximately 58 months)
From study start through end of study (Up to approximately 58 months)
Parts 1-5: Number of Participants With Serum Treatment-emergent Anti-drug Antibody (ADA) Formation to RO7446603
Time Frame: From study start through end of study (Up to approximately 58 months)
From study start through end of study (Up to approximately 58 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GR43828
  • ISRCTN14152148 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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