Phase 2
Completed N=187
A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
Source: ClinicalTrials.gov NCT05151744 ↗Enrolled (actual)
187
Serious AEs
20.9%
Results posted
Oct 2025
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants — 12.8; 9.4 letters — p=0.0625
Summary
Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.
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 |
12.8; 9.4 | 0.0625 |
| SECONDARY Number of Participants With Systemic and Ocular Adverse Events (AEs) |
54; 60; 33; 28; 25; 27 | — |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants |
11.1; 8.4 | 0.2052 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population |
12.4; 9.1 | 0.0192 sig |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants |
11.8; 9.3 | 0.0637 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants |
8.3; 7.5 | 0.7091 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population |
10.6; 8.7 | 0.1107 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants |
10.6; 8.5 | 0.1498 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants |
8.1; 6.2 | 0.3783 |
| SECONDARY Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population |
9.7; 7.8 | 0.1036 |
| SECONDARY Change From Baseline in BCVA Over Time in Overall ITT Population |
62.6; 62.0; 6.7; 4.2; 7.6; 4.6 | — |
| SECONDARY Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population |
98.9; 98.9; 94.6; 90.4; 76.3; 69.1 | — |
| SECONDARY Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population |
19.4; 27.7; 7.5; 11.7; 4.3; 6.4 | — |
| SECONDARY Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time |
34.4; 31.9; 53.4; 48.9; 63.0; 53.3 | — |
| SECONDARY Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time |
0; 0; 2.3; 0; 6.5; 2.2 | — |
| SECONDARY Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time |
3.2; 4.3; 2.3; 2.2; 2.2; 3.3 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants |
-202.4; -192.4 | 0.4968 |
| SECONDARY Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants |
-194.4; -171.2 | 0.3951 |
| SECONDARY Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population |
-201.6; -178.8 | 0.0521 |
| SECONDARY Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants |
-197.9; -180.3 | 0.2227 |
| SECONDARY Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants |
-177.2; -150.0 | 0.2972 |
| SECONDARY Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population |
-191.4; -172.1 | 0.1071 |
| SECONDARY Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants |
-184.3; -169.7 | 0.3030 |
| SECONDARY Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants |
-163.2; -120.2 | 0.0878 |
| SECONDARY Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population |
-176.1; -153.9 | 0.1111 |
| SECONDARY Change From Baseline in CST Over Time in Overall ITT Population |
493.0; 498.4; -121.0; -92.2; -138.9; -108.2 | — |
| SECONDARY Percentage of Participants With Absence of DME Over Time in Overall ITT Population |
0; 2.1; 31.1; 25.8; 45.3; 37.8 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population |
19.6; 22.3; 53.9; 47.8; 60.5; 51.1 | — |
| SECONDARY Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population |
60.4; 63.8; 89.9; 82.2; 98.9; 93.4 | — |
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 (NCT05151744). 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. Informational only — not medical advice.