18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive ParticipantsPrimary· Baseline, Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
10.3
8.8 – 11.9
Arm B: 1.5 mg Faricimab
11.7
10.1 – 13.3
Arm C: 6 mg Faricimab
13.9
12.2 – 15.6
Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated ParticipantsSecondary· Baseline, Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
8.9
5.7 – 10.8
Arm C: 6 mg Faricimab
9.6
7.0 – 12.3
Mean Change From Baseline in BCVA Letter Score at Week 24, in All ParticipantsSecondary· Baseline, Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
9.4
8.1 – 10.7
Arm B: 1.5 mg Faricimab
11.7
10.0 – 13.4
Arm C: 6 mg Faricimab
12.3
10.9 – 13.7
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive ParticipantsSecondary· Baseline, Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
35.3
27.3 – 44.1
Arm B: 1.5 mg Faricimab
36.0
27.9 – 45.0
Arm C: 6 mg Faricimab
42.5
33.5 – 52.1
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated ParticipantsSecondary· Baseline up to Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
16.8
9.6 – 27.8
Arm C: 6 mg Faricimab
23.2
14.1 – 35.7
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All ParticipantsSecondary· Baseline up to Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
28.7
22.7 – 35.5
Arm B: 1.5 mg Faricimab
35.3
27.4 – 44.2
Arm C: 6 mg Faricimab
35.9
28.9 – 43.6
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
69.0
60.2 – 76.7
Arm B: 1.5 mg Faricimab
78.5
70.3 – 84.9
Arm C: 6 mg Faricimab
75.8
66.8 – 83.0
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
69.0
57.3 – 78.7
Arm C: 6 mg Faricimab
68.4
55.4 – 79.0
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
69.0
62.1 – 75.2
Arm B: 1.5 mg Faricimab
78.9
70.8 – 85.2
Arm C: 6 mg Faricimab
73.2
65.9 – 79.4
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
11.5
6.9 – 18.7
Arm B: 1.5 mg Faricimab
8.7
4.8 – 15.3
Arm C: 6 mg Faricimab
9.8
5.5 – 16.8
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
10.5
5.0 – 20.6
Arm C: 6 mg Faricimab
8.2
3.3 – 19.1
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All ParticipantsSecondary· Week 24
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured 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 examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits a
Group
Value
95% CI
Arm A: 0.3 mg Ranibizumab
11.1
7.3 – 16.6
Arm B: 1.5 mg Faricimab
10.6
6.2 – 17.5
Arm C: 6 mg Faricimab
9.1
5.6 – 14.6
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline until the final study visit (up to 36 weeks).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D
· Phase 1
· recruiting
NCT07520045 — Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
· NA
· recruiting
NCT07088445 — Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration
· not yet recruiting
NCT06908876 — A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
· Phase 2
· recruiting
NCT06795048 — A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macu
· Phase 4
· active not recruiting
Other recruiting trials for Diabetic Macular Edema
Currently open trials in the same condition.
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D
· Phase 1
· recruiting
NCT06984822 — Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
· NA
· recruiting
NCT07038967 — Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
· recruiting
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· recruiting
NCT06549023 — Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 25 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02699450.