| 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 and which does not necessarily have to have a causal relationship with this treatment. 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. Only one eye was selected as the study eye, while the other was referred to as the fellow eye. | Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. | Posted | | Count of Participants | | Participants | | Up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72. | | OG003 | Arm D: Ranibizumab 0.5 mg Q4W | Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72. |
| | Units | Counts |
|---|
| Participants | - OG00094
- OG001100
- OG00298
- OG003
|
| | Title | Denominators | Categories |
|---|
| Systemic AEs | | | Title | Measurements |
|---|
| - OG00043
- OG00158
- OG00254
- OG003
|
|
| |
| Secondary | Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in BCVA Over Time, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| 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 | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. | Overall ITT population included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Number | | percentage of participants | | From baseline up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. | Overall ITT population included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Number | | percentage of participants | | From baseline up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. | Overall ITT population included all randomized participants. 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 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. | Overall ITT population included all randomized participants. 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 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population | The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. | Overall ITT population included all randomized participants. 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 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants | CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | micrometers (µm) | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
|
| Secondary | Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72. |
|
| Secondary | Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
|
| Secondary | Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
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| Secondary | Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 32 and 36 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72. |
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| Secondary | Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
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| Secondary | Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
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| Secondary | Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. | Posted | | Mean | Standard Error | µm | | Baseline, Weeks 20 and 24 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72. |
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| Secondary | Change From Baseline in CST Over Time, in Overall Enrolled Population | CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. | Overall ITT population included all randomized participants. 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, 72 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG002 | Arm C: Vamikibart 1 mg Q4W |
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| Secondary | Percentage of Participants With Absence of DME Over Time, in Overall Enrolled 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. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized. | Overall ITT population included all randomized participants. 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, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | |
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| Secondary | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled 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 the absence of IRF at the foveal center were reported. Percentages have been summarized. | Overall ITT population included all randomized participants. 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 |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. |
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| 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 were reported. Percentages have been summarized. | Overall ITT population included all randomized participants. 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 |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | |
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| Primary | Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants | The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported. | Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-vascular endothelial growth factor (VEGF) or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization. | Posted | | Mean | Standard Error | ETDRS letters | | Baseline, Weeks 44 and 48 | | | | ID | Title | Description |
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| OG000 | Arm A: Vamikibart 0.25 mg Q8W | Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72. | | OG001 | Arm B: Vamikibart 1 mg Q8W | |
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