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Diabetic Macular EdemaPhase 1/2THAMESNCT06850922

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

A Phase 1/2 study testing RO7446603, Aflibercept and Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 77 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
RO7446603, Aflibercept and Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
77 sitesin 3 countries
Study dates
22 Jun 2022to 19 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

77 sites in 3 countries.

77 sites in 3 countries

United States70 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909-6440

  • University of Colorado - Eye Center - PPDS

    Aurora, Colorado, 80045-2517

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401

  • Cincinnati Eye Institute

    Blue Ash, Ohio, 45242-5537

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • North Carolina Retina Associates

    Cary, North Carolina, 27511

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44016

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado, 80909

  • Ohio State Eye and Ear Institute

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Retina Specialists of Colorado

    Denver, Colorado, 80222

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Erie Retina Research

    Erie, Pennsylvania, 16505

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Long Island Vitreoretinal Consultants;Opthalmology

    Hauppauge, New York, 11788

  • Graystone Eye-Hickory

    Hickory, North Carolina, 28602

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana, 46290

  • Florida Retina Institute

    Jacksonville, Florida, 32216-6347

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York, 13088

  • Advanced Vision Research Institute

    Longmont, Colorado, 80503-6499

  • Opthalmic Consultants of LI

    Lynbrook, New York, 11563

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502-4271

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Valley Retina Institute P.A.

    McAllen, Texas, 78550-9207

  • Retinal Consultants Medical Group

    Modesto, California, 95356-9412

  • Northern California Retina-Vitreous Associates

    Mountain View, California, 94040

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107-5109

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85020-5917

  • Associated Retinal Consultants PC

    Phoenix, Arizona, 85020

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • Virginia Eye Institute - Richmond - 7301 Forest Ave

    Richmond, Virginia, 23230

  • Retina Institute of Virginia

    Richmond, Virginia, 23235-1962

  • Associated Retinal Consultants - Royal Oak

    Royal Oak, Michigan, 48073

  • Retinal Consultants Medical Group

    Sacramento, California, 95825

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota, 55416

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah, 84107

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78240

  • Brown Retina Institute

    San Antonio, Texas, 78251-4551

  • University of California San Francisco

    San Francisco, California, 94158

  • Sewickely Eye Group

    Sewickley, Pennsylvania, 15143

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas, 72764

  • Cascade Medical Research Institute LLC

    Springfield, Oregon, 97477

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa, Florida, 33609

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Macula Retina Vitreous Research Institute

    Torrance, California, 90503-3270

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114

  • North Carolina (NC) Retina Associates - Wake Forest Office

    Wake Forest, North Carolina, 27587-3803

  • Chesapeake Retina Centers - Waldorf

    Waldorf, Maryland, 20602

  • Bay Area Retina Associates;Study Department

    Walnut Creek, California, 94598

  • Retina Group of New England

    Waterford, Connecticut, 06385-1215

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169-2429

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Piedmont Retina Specialists

    Winston-Salem, North Carolina, 27103-6970

Other trials in United States

China6 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Shanghai General Hospital - North Campus

    Shanghai, Shanghai Municipality, 200080

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality, 300384

  • Eye Hospital,WMU(Zhejiang Eye Hospital)

    Wenzhou, Zhejiang, 325027

Other trials in China

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

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

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.

Being tested
RO7446603, Aflibercept, Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7446603Drug

    Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.

  • AfliberceptDrug

    Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.

  • FaricimabDrug

    Also called Vabysmo

    Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.

Study groups in NCT06850922
Study groupRoleWhat they receive
Part 1: Single Ascending Dose (SAD) StageExperimentalParticipants received a single dose of RO7446603 at five different dose levels as IVT injection on Day 1.
Receives: Drug: RO7446603
Part 2: Multiple Dose (MD) Monotherapy StageExperimentalParticipants received four different dose levels of RO7446603 (two doses at each planned dose level) as IVT injection, every 8 weeks (Q8W).
Receives: Drug: RO7446603
Part 3: MD Co-administration With Aflibercept StageExperimentalParticipants 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).
Receives: Drug: RO7446603; Drug: Aflibercept
Part 4: MD Co-administration With Faricimab StageExperimentalParticipants 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.
Receives: Drug: RO7446603; Drug: Faricimab
Part 5: MD Co-mixed With Faricimab StageExperimentalParticipants 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.
Receives: Drug: RO7446603; Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1-5: Percentage of Participants With Adverse Events (AEs)

    Measured: From study start through end of study (Up to approximately 58 months)

  2. Parts 1-5: Percentage of Participants With Ocular AEs

    Measured: From study start through end of study (Up to approximately 58 months)

  3. Part 1: Change in Best Corrected Visual Acuity (BCVA) Over Time

    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.

    Measured: From Baseline up to Week 16

  4. Parts 2-4: Change in BCVA Over Time

    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.

    Measured: From Baseline up to Week 28

  5. Part 5: Change From Baseline in BCVA Averaged Over Weeks 52 and 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.

    Measured: From Baseline up to Week 56

Secondary outcomes (7)

  1. Part 5: Proportion of Participants Gaining ≥ 15 Letters in BCVA From Baseline Averaged Over Weeks 52 and 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.

    Measured: From Baseline up to Week 56

  2. Part 5: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time

    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.

    Measured: From Baseline up to Week 56

  3. Part 5: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time

    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.

    Measured: From Baseline up to Week 56

  4. Part 5: Change From Baseline in BCVA Score Over Time

    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.

    Measured: From Baseline up to Week 56

  5. Parts 1-4: Serum Concentration of RO7446603 Total Fab

    Measured: Part 1: From Baseline up to Week 16; Parts 2-4: From Baseline up to Week 28

  6. Parts 1-5: Aqueous Humor Concentration of RO7446603 Measured as Total Fab

    Measured: From study start through end of study (Up to approximately 58 months)

  7. Parts 1-5: Number of Participants With Serum Treatment-emergent Anti-drug Antibody (ADA) Formation to RO7446603

    Measured: From study start through end of study (Up to approximately 58 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start22 Jun 2022
  3. Primary completion19 May 2026
  4. Study completion19 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06850922
Sponsor's protocol ID
GR43828
Other IDs
ISRCTN14152148
Acronym
THAMES
Status last verified
Jun 2026
First submitted
26 Feb 2025
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RO7446603, Aflibercept and Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 77 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, China, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1-5: Percentage of Participants With Adverse Events (AEs) (time frame: From study start through end of study (Up to approximately 58 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06850922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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