Phase 2
N=394
A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT05151731 ↗Enrolled (actual)
394
Serious AEs
21.3%
Results posted
May 2026
Primary outcome: Primary: Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants — 7.1; 4.6; 5.5; 13.0 ETDRS letters — p=0.0012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vamikibart (Drug); Ranibizumab (Drug); Sham Procedure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants |
7.1; 4.6; 5.5; 13.0 | 0.0012 sig |
| SECONDARY Number of Participants With Systemic and Ocular Adverse Events (AEs) |
43; 58; 54; 65; 39; 46 | — |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants |
2.0; -0.5; -0.4; 9.6 | 0.0340 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population |
5.2; 3.3; 3.8; 11.7 | <0.0001 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants |
5.8; 3.4; 5.8; 13.0 | <0.0001 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants |
2.0; 3.4; 4.4; 8.5 | 0.0003 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population |
4.4; 3.6; 5.5; 11.4 | <0.0001 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants |
6.4; 3.5; 5.3; 11.1 | 0.0051 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants |
2.7; 2.8; 5.4; 8.4 | 0.0020 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population |
5.1; 3.3; 5.4; 10.2 | <0.0001 sig |
| SECONDARY Change From Baseline in BCVA Over Time, in Overall Enrolled Population |
3.0; 2.3; 3.8; 6.2; 4.3; 3.3 | — |
| SECONDARY Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population |
97.9; 98.0; 99.0; 100; 79.8; 83.0 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population |
70.2; 61.0; 64.3; 83.7; 85.1; 80.0 | — |
| SECONDARY Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population |
34.7; 32.7; 43.9; 35.0; 45.6; 44.3 | — |
| SECONDARY Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population |
1.1; 1.0; 0; 1.0; 2.2; 0 | — |
| SECONDARY Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population |
1.1; 1.0; 1.0; 1.0; 2.2; 3.1 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants |
-68.4; -50.8; -67.5; -174.2 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants |
-40.9; -81.4; -75.8; -185.7 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population |
-57.3; -61.1; -70.5; -176.9 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants |
-57.1; -46.9; -64.8; -163.9 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants |
-35.4; -90.5; -81.5; -168.5 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population |
-47.6; -62.1; -69.4; -164.8 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants |
-48.5; -68.8; -68.5; -150.4 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants |
-5.7; -81.7; -68.7; -146.4 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population |
-36.1; -72.9; -69.0; -148.1 | <0.0001 sig |
| SECONDARY Change From Baseline in CST Over Time, in Overall Enrolled Population |
-25.7; -26.6; -36.3; -106.9; -31.2; -34.0 | — |
| SECONDARY Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population |
3.2; 1.0; 4.1; 6.0; 6.8; 8.4 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population |
22.1; 15.2; 24.7; 25.0; 21.6; 26.6 | — |
| SECONDARY Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population |
62.1; 61.6; 68.0; 67.0; 70.5; 71.6 | — |
Summary
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Willingness to allow Aqueous Humor collection
- For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of ) 12%
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Prior treatment with panretinal photocoagulation or macular laser to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
- Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
- Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
- Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeks prior to Day 1) in either eye
- Any proliferative diabetic retinopathy
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT05151731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.