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Completed

NCT Number: NCT06850922

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7446603

Drug

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

aflibercept

Drug

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

Faricimab

Drug

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

Other names: Vabysmo

Primary outcomes

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

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

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

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

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Acronym: THAMES

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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