A Study to Investigate Vamikibart (RO7200220) in Combinat... | NCT05151744

ID	Type	Description	Link
2021-004390-31	EudraCT Number

Label	Type	Description	Intervention Names
Arm A: Vamikibart + Ranibizumab	Experimental	Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.	Drug: Vamikibart Drug: Ranibizumab
Arm B: Ranibizumab	Active Comparator	Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.	Drug: Ranibizumab Other: Sham Procedure

Name	Type	Description	Arm Group Labels	Other Names
Vamikibart	Drug	Vamikibart will be administered by IVT injection in the study eye.	Arm A: Vamikibart + Ranibizumab

Measure	Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants	BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision^TM 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 BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) model.	Baseline, Week 44 and Week 48

Measure	Description	Time Frame
Number of Participants With Systemic and Ocular Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Win Retina		Arcadia	California	91006	United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

ID	Title	Description
FG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 milligrams (mg) as intravitreal (IVT) injection, every 4 weeks (Q4W) in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
FG001	Arm B: Ranibizumab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 23, 2023	Sep 30, 2025

Primary

Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants

BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision^TM 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 BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) model.

Treatment naïve ITT population included all randomized participants who were IVT anti-vascular endothelial growth factor (anti-VEGF) or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants	OG00061 OG00163

Title

Denominators

Categories

Title	Measurements
	OG00012.8± 1.30 OG0019.4± 1.25

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.0625		Difference in Adjusted Means	3.4			2-Sided	95	-0.2	7.0					Superiority

Secondary

Number of Participants With Systemic and Ocular Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs.

Safety Population included all participants randomized to study treatment and received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Posted

Count of Participants

Participants

Up to Week 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

letters

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Treatment-naïve ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

letters

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Treatment naïve ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

letters

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

letters

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Change From Baseline in BCVA Over Time in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Mean

Standard Error

letters

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Number

percentage of participants

Up to Week 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Number

percentage of participants

Up to Week 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

percentage of participants

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

percentage of participants

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time

BCVA was measured via ETDRS chart at a starting distance of 4 meters using a set of three Precision vision^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. Higher scores indicate improvement in VA. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

percentage of participants

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Secondary

Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. CST was measured using spectral domain optical coherence tomography (SD-OCT). Negative change from baseline values denotes improvement. This analysis used a MMRM model.

Treatment naïve ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

μm

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used a MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

micrometre (μm)

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

μm

Baseline, Week 44 and Week 48

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Treatment naïve ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

μm

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

μm

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

μm

Baseline, Week 32 and Week 36

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Treatment naïve ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids treatment-naïve as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

μm

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Previously treated ITT population included all randomized participants who were IVT anti-VEGF or periocular/IVT corticosteroids previously treated participants as defined in the exclusion criteria 9 and 10 in the protocol.

Posted

Mean

Standard Error

μm

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

μm

Baseline, Week 20 and Week 24

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Change From Baseline in CST Over Time in Overall ITT Population

CST was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 mm central subfield. CST was measured using SD-OCT. Negative change from baseline values denotes improvement. This analysis used an MMRM model.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Mean

Standard Error

μm

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Percentage of Participants With Absence of DME Over Time in Overall ITT Population

Absence of DME was defined as CST < 325 μm for Spectralis SD-OCT, or < 315 μm for Cirrus SD-OCT or Topcon SD-OCT. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts
Participants

Secondary

Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population

The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of IRF at foveal center are reported. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

percentage of participants

Baseline, Weeks 4, 12, 24, 36, 48, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

Secondary

Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population

The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center are reported. Percentages have been rounded off.

Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Number

percentage of participants

Baseline, Weeks 4, 12, 24, 36, 48, and 72

ID	Title	Description
OG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
OG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.

Units	Counts

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.	1	93	22	93	38	93
EG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.	2	94	17	94	48	94

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected93 at risk EG0010 events0 affected94 at risk
Cataract subcapsular	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected94 at risk
Eye inflammation	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Glaucoma	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Iritis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Ocular hypertension	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Retinal occlusive vasculitis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected93 at risk EG0010 events0 affected94 at risk
Vitritis	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected93 at risk EG0010 events0 affected94 at risk
Diabetic gastropathy	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Endophthalmitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Herpes ophthalmic	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Osteomyelitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Soft tissue infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected94 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected93 at risk EG0010 events0 affected94 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected94 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected93 at risk EG0010 events0 affected94 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Nephropathy	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected94 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected94 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected94 at risk
Angina unstable	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Brain death	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected94 at risk
Hemiparesis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected94 at risk
Haematoma	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected94 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0007 events5 affected93 at risk EG0013 events3 affected94 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 27.1	Systematic Assessment	EG00012 events8 affected93 at risk EG0018 events8 affected94 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected93 at risk EG00116 events16 affected94 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected93 at risk EG0012 events2 affected94 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected93 at risk EG0017 events7 affected94 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected93 at risk EG00110 events8 affected94 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected93 at risk EG0016 events6 affected94 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0008 events7 affected93 at risk EG0019 events9 affected94 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected93 at risk EG0016 events5 affected94 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Arm A: Vamikibart + Ranibizumab	Participants received vamikibart, 1 mg as IVT injection, Q4W in combination with ranibizumab, 0.5 mg as IVT injection, Q4W up to Week 44 followed by an observational period up to Week 72.
BG001	Arm B: Ranibizumab	Participants received ranibizumab, 0.5 mg as an IVT injection, Q4W in combination with sham treatment up to Week 44 followed by an observational period up to Week 72.
BG002	Total	Total of all reporting groups