Diabetic Macular Edema
Conditions
Brief summary
Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.
Interventions
DRUGVamikibart
Vamikibart will be administered by IVT injection in the study eye.
DRUGRanibizumab
Ranibizumab will be administered by IVT injection in the study eye.
OTHERSham Procedure
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of diabetes mellitus (Type 1 or Type 2) * Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula * Decreased visual acuity attributable primarily to DME * Ability and willingness to provide written informed consent and to comply with the study protocol * Willingness to allow Aqueous Humor collection * For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of \<1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
Exclusion criteria
* Hemoglobin A1c (HbA1c) of greater than (\>) 12% * Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest * Currently pregnant or breastfeeding, or intend to become pregnant during the study * Prior treatment with panretinal photocoagulation or macular laser to the study eye * Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye * Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye * Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo\^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted * Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: \</=24 weeks prior to Day 1) in either eye * Any proliferative diabetic retinopathy * Active intraocular or periocular infection or active intraocular inflammation in the study eye * Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye * Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye * Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | Baseline, Week 44 and Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants | Baseline, Week 44 and Week 48 | 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. |
| Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population | Baseline, Week 44 and Week 48 | 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. |
| Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in BCVA Over Time in Overall ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
| Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Up to Week 72 | 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. |
| Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Up to Week 72 | 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. |
| Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
| Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
| Number of Participants With Systemic and Ocular Adverse Events (AEs) | Up to Week 72 | 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. |
| Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | Baseline, Week 44 and Week 48 | 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. |
| Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants | Baseline, Week 44 and Week 48 | 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. |
| Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population | Baseline, Week 44 and Week 48 | 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. |
| Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population | Baseline, Week 32 and Week 36 | 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. |
| Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population | Baseline, Week 20 and Week 24 | 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. |
| Change From Baseline in CST Over Time in Overall ITT Population | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
| Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Baseline, Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
| Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Baseline, Weeks 4, 12, 24, 36, 48, and 72 | 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. |
| Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Baseline, Weeks 4, 12, 24, 36, 48, and 72 | 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. |
| Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 | 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. |
Countries
Argentina, Canada, Israel, Poland, Puerto Rico, South Korea, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 187 participants with diabetic macular edema (DME) took part in the study at 37 investigative sites across the United States, Argentina, Israel, South Korea, Poland, Canada, Spain, and the United Kingdom from 17 December 2021 to 1 October 2024.
Pre-assignment details
Participants were randomized in 1:1 ratio to Vamikibart + Ranibizumab arm and Ranibizumab arm.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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. | 94 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Need for Rescue Treatment | 0 | 1 |
| Overall Study | Non-compliance with Study Drug | 0 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Reason not Specified | 10 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Arm B: Ranibizumab | Total | Arm A: Vamikibart + Ranibizumab |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 9.3 | 61.9 years STANDARD_DEVIATION 9.7 | 61.7 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 20 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 112 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants | 55 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants | 72 Participants | 41 Participants |
| Race (NIH/OMB) White | 60 Participants | 105 Participants | 45 Participants |
| Sex: Female, Male Female | 39 Participants | 70 Participants | 31 Participants |
| Sex: Female, Male Male | 55 Participants | 117 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 93 | 2 / 94 |
| other Total, other adverse events | 38 / 93 | 48 / 94 |
| serious Total, serious adverse events | 22 / 93 | 17 / 94 |
Outcome results
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.
Time frame: Baseline, Week 44 and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | 12.8 letters | Standard Error 1.3 |
| Arm B: Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | 9.4 letters | Standard Error 1.25 |
p-value: 0.062595% CI: [-0.2, 7]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population | -191.4 μm | Standard Error 8.51 |
| Arm B: Ranibizumab | Change From Baseline Averaged Over Week 32 and Week 36 in Overall ITT Population | -172.1 μm | Standard Error 8.38 |
p-value: 0.107195% CI: [-42.9, 4.2]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population | 9.7 letters | Standard Error 0.84 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall ITT Population | 7.8 letters | Standard Error 0.83 |
p-value: 0.103695% CI: [-0.4, 4.3]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants | 8.1 letters | Standard Error 1.46 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Previously Treated Participants | 6.2 letters | Standard Error 1.47 |
p-value: 0.378395% CI: [-2.3, 6]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | 10.6 letters | Standard Error 1.04 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | 8.5 letters | Standard Error 1.01 |
p-value: 0.149895% CI: [-0.8, 5]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population | 10.6 letters | Standard Error 0.81 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall ITT Population | 8.7 letters | Standard Error 0.8 |
p-value: 0.110795% CI: [-0.4, 4.1]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants | 8.3 letters | Standard Error 1.43 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants | 7.5 letters | Standard Error 1.46 |
p-value: 0.709195% CI: [-3.3, 4.9]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants | 11.8 letters | Standard Error 0.97 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants | 9.3 letters | Standard Error 0.94 |
p-value: 0.063795% CI: [-0.1, 5.2]MMRM
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.
Time frame: Baseline, Week 44 and Week 48
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population | 12.4 letters | Standard Error 0.99 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population | 9.1 letters | Standard Error 0.96 |
p-value: 0.019295% CI: [0.5, 6]MMRM
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.
Time frame: Baseline, Week 44 and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants | 11.1 letters | Standard Error 1.5 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants | 8.4 letters | Standard Error 1.49 |
p-value: 0.205295% CI: [-1.5, 7]MMRM
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 60 | 10.4 letters | Standard Error 1.18 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 28 | 10.1 letters | Standard Error 0.87 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 12 | 8.9 letters | Standard Error 0.78 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 32 | 10.5 letters | Standard Error 0.88 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 36 | 10.6 letters | Standard Error 0.84 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 56 | 10.8 letters | Standard Error 1.13 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 16 | 9.3 letters | Standard Error 0.83 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 44 | 12.2 letters | Standard Error 1.01 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 40 | 10.9 letters | Standard Error 0.95 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 48 | 12.5 letters | Standard Error 1.03 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 52 | 11.1 letters | Standard Error 1.07 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 20 | 9.7 letters | Standard Error 0.81 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 64 | 10.2 letters | Standard Error 1.12 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 68 | 9.9 letters | Standard Error 1.14 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Baseline | 62.6 letters | Standard Error 1.02 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 72 | 9.2 letters | Standard Error 1.12 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 4 | 6.7 letters | Standard Error 0.64 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 24 | 9.8 letters | Standard Error 1.03 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 8 | 7.6 letters | Standard Error 0.76 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 24 | 8.0 letters | Standard Error 1.02 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 32 | 8.8 letters | Standard Error 0.87 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 48 | 9.4 letters | Standard Error 1 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 52 | 8.0 letters | Standard Error 1.03 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 56 | 7.8 letters | Standard Error 1.09 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 64 | 8.2 letters | Standard Error 1.1 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 68 | 7.6 letters | Standard Error 1.11 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 72 | 7.8 letters | Standard Error 1.11 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 12 | 6.4 letters | Standard Error 0.78 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 16 | 7.4 letters | Standard Error 0.83 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 20 | 7.6 letters | Standard Error 0.8 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 8 | 4.6 letters | Standard Error 0.76 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 28 | 8.5 letters | Standard Error 0.87 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 36 | 8.6 letters | Standard Error 0.83 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 40 | 8.8 letters | Standard Error 0.93 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 44 | 8.7 letters | Standard Error 0.99 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 60 | 7.7 letters | Standard Error 1.14 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Baseline | 62.0 letters | Standard Error 1.01 |
| Arm B: Ranibizumab | Change From Baseline in BCVA Over Time in Overall ITT Population | Change at Week 4 | 4.2 letters | Standard Error 0.65 |
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.
Time frame: Baseline, Week 44 and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | -202.4 μm | Standard Error 10.63 |
| Arm B: Ranibizumab | Change From Baseline in Central Subfield Thickness (CST) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants | -192.4 μm | Standard Error 10.11 |
p-value: 0.496895% CI: [-38.9, 18.9]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population | -176.1 μm | Standard Error 9.89 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Overall ITT Population | -153.9 μm | Standard Error 9.8 |
p-value: 0.111195% CI: [-49.8, 5.2]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants | -163.2 μm | Standard Error 17.75 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Previously Treated Participants | -120.2 μm | Standard Error 17.65 |
p-value: 0.087895% CI: [-92.4, 6.4]MMRM
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.
Time frame: Baseline, Week 20 and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | -184.3 μm | Standard Error 10.05 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 20 and Week 24 in Treatment-naïve Participants | -169.7 μm | Standard Error 9.89 |
p-value: 0.30395% CI: [-42.4, 13.2]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants | -177.2 μm | Standard Error 18.38 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 32 and Week 36 in Previously Treated Participants | -150.0 μm | Standard Error 18.38 |
p-value: 0.297295% CI: [-78.6, 24.2]MMRM
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.
Time frame: Baseline, Week 32 and Week 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants | -197.9 μm | Standard Error 10.26 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 32 and Week 36 in Treatment-naïve Participants | -180.3 μm | Standard Error 9.97 |
p-value: 0.222795% CI: [-45.7, 10.7]MMRM
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.
Time frame: Baseline, Week 44 and Week 48
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population | -201.6 μm | Standard Error 8.33 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 44 and Week 48 in Overall ITT Population | -178.8 μm | Standard Error 8.15 |
p-value: 0.052195% CI: [-45.8, 0.2]MMRM
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.
Time frame: Baseline, Week 44 and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants | -194.4 micrometre (μm) | Standard Error 19.58 |
| Arm B: Ranibizumab | Change From Baseline in CST Averaged Over Week 44 and Week 48 in Previously Treated Participants | -171.2 micrometre (μm) | Standard Error 18.79 |
p-value: 0.395195% CI: [-76.8, 30.5]MMRM
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 32 | -186.4 μm | Standard Error 8.87 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 20 | -172.8 μm | Standard Error 10.11 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 4 | -121.0 μm | Standard Error 9.82 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 24 | -174.1 μm | Standard Error 10.12 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 40 | -193.4 μm | Standard Error 8.92 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 56 | -173.8 μm | Standard Error 11.43 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 44 | -197.3 μm | Standard Error 8.95 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 8 | -138.9 μm | Standard Error 9.67 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 48 | -200.1 μm | Standard Error 9.04 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 28 | -181.1 μm | Standard Error 10.53 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 52 | -172.7 μm | Standard Error 12.92 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 12 | -147.9 μm | Standard Error 9.63 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 60 | -155.5 μm | Standard Error 13.18 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 36 | -191.1 μm | Standard Error 9.58 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 64 | -161.4 μm | Standard Error 13.65 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 16 | -158.6 μm | Standard Error 10.28 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 68 | -160.1 μm | Standard Error 11.26 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 72 | -159.5 μm | Standard Error 11.62 |
| Arm A: Vamikibart + Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Baseline | 493.0 μm | Standard Error 11.55 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 72 | -154.3 μm | Standard Error 11.55 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 24 | -152.9 μm | Standard Error 10.02 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 28 | -154.1 μm | Standard Error 10.38 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 32 | -165.6 μm | Standard Error 8.77 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 36 | -174.9 μm | Standard Error 9.33 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 56 | -129.2 μm | Standard Error 10.99 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 68 | -136.6 μm | Standard Error 10.96 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Baseline | 498.4 μm | Standard Error 14.1 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 4 | -92.2 μm | Standard Error 9.77 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 8 | -108.2 μm | Standard Error 9.59 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 12 | -125.3 μm | Standard Error 9.54 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 16 | -138.3 μm | Standard Error 10.19 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 20 | -149.8 μm | Standard Error 10 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 40 | -166.7 μm | Standard Error 8.76 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 44 | -172.7 μm | Standard Error 8.73 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 48 | -179.2 μm | Standard Error 8.84 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 52 | -136.9 μm | Standard Error 12.25 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 60 | -130.6 μm | Standard Error 12.65 |
| Arm B: Ranibizumab | Change From Baseline in CST Over Time in Overall ITT Population | Change at Week 64 | -163.0 μm | Standard Error 13.44 |
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.
Time frame: Up to Week 72
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Systemic AEs | 54 Participants |
| Arm A: Vamikibart + Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Ocular AEs in Study Eyes | 33 Participants |
| Arm A: Vamikibart + Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Ocular AEs in Fellow Eyes | 25 Participants |
| Arm B: Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Systemic AEs | 60 Participants |
| Arm B: Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Ocular AEs in Study Eyes | 28 Participants |
| Arm B: Ranibizumab | Number of Participants With Systemic and Ocular Adverse Events (AEs) | Ocular AEs in Fellow Eyes | 27 Participants |
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.
Time frame: Up to Week 72
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 5 Letters | 94.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 0 Letters | 98.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 15 Letters | 49.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 10 Letters | 76.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 15 Letters | 44.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 0 Letters | 98.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 10 Letters | 69.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time in Overall ITT Population | Participants Gaining ≥ 5 Letters | 90.4 percentage of participants |
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.
Time frame: Up to Week 72
Population: Overall ITT population included all randomized participants grouped according to the treatment assigned at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 10 Letters | 7.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 15 Letters | 4.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 5 Letters | 19.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 10 Letters | 11.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 5 Letters | 27.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants Losing ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA Over Time in Overall ITT Population | Participants Losing ≥ 15 Letters | 6.4 percentage of participants |
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 20 | 64.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 40 | 77.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 12 | 47.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 44 | 80.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 24 | 65.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 48 | 79.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 8 | 45.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 52 | 70.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 28 | 75.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 56 | 67.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 16 | 57.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 60 | 62.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 32 | 75.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 64 | 59.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 4 | 31.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 68 | 58.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 36 | 75.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 72 | 61.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Baseline | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 72 | 62.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Baseline | 2.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 4 | 25.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 8 | 37.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 12 | 46.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 16 | 49.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 20 | 60.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 24 | 66.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 28 | 66.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 32 | 67.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 36 | 73.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 40 | 70.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 44 | 75.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 48 | 72.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 52 | 55.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 56 | 57.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 60 | 62.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 64 | 62.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of DME Over Time in Overall ITT Population | Week 68 | 61.2 percentage of 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.
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 12 | 60.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 36 | 70.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 4 | 53.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 48 | 78.8 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 24 | 69.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 72 | 71.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Baseline | 19.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 72 | 75.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Baseline | 22.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 4 | 47.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 12 | 51.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 24 | 69.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 36 | 71.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time in Overall ITT Population | Week 48 | 78.2 percentage of participants |
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.
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 12 | 98.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 36 | 100 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 4 | 89.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 48 | 98.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 24 | 98.8 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 72 | 98.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Baseline | 60.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 72 | 100 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Baseline | 63.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 4 | 82.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 12 | 93.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 24 | 96.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 36 | 96.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time in Overall ITT Population | Week 48 | 97.4 percentage of participants |
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 1 | 2.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 12 | 2.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 40 | 2.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 16 | 1.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 44 | 1.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Baseline | 3.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 48 | 0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 20 | 1.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 52 | 1.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 4 | 2.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 56 | 3.0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 24 | 2.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 60 | 1.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 36 | 1.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 64 | 1.8 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 28 | 3.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 68 | 1.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 8 | 2.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 72 | 0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 32 | 2.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 72 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Baseline | 4.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 1 | 2.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 4 | 3.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 8 | 3.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 16 | 1.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 20 | 2.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 24 | 1.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 28 | 2.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 32 | 1.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 36 | 1.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 40 | 2.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 44 | 1.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 48 | 1.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 52 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 56 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 60 | 1.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 64 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 68 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≤ 38 Letters (20/200 Snellen Equivalent) Over Time | Week 12 | 2.2 percentage of participants |
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 64 | 82.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 4 | 63.0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 8 | 67.0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 12 | 73.0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 20 | 74.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 24 | 70.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 28 | 71.8 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 40 | 78.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 44 | 82.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 48 | 80.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 68 | 81.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 72 | 82.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Baseline | 34.4 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 16 | 69.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 32 | 78.8 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 36 | 72.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 52 | 78.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 56 | 82.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 60 | 82.0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 1 | 53.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 60 | 68.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 1 | 48.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 72 | 71.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 36 | 62.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Baseline | 31.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 16 | 57.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 4 | 53.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 20 | 67.0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 8 | 48.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 12 | 56.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 28 | 63.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 56 | 58.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 40 | 70.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 24 | 61.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 44 | 67.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 52 | 64.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 48 | 70.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 64 | 69.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 32 | 62.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time | Week 68 | 71.4 percentage of participants |
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.
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 24 | 17.6 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 8 | 10.2 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 28 | 12.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 44 | 23.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 32 | 17.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 4 | 6.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 36 | 13.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 48 | 23.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 52 | 15.7 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Baseline | 0 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 56 | 14.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 12 | 10.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 60 | 13.1 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 16 | 13.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 64 | 19.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 1 | 2.3 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 68 | 18.9 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 20 | 14.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 72 | 11.5 percentage of participants |
| Arm A: Vamikibart + Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 40 | 12.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 72 | 11.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 1 | 0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 4 | 2.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 8 | 5.6 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 36 | 12.0 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 40 | 11.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 44 | 8.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 12 | 8.7 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 16 | 6.9 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 20 | 8.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 24 | 8.1 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 28 | 11.5 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 32 | 13.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 48 | 14.8 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 52 | 7.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 56 | 9.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 60 | 9.4 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 64 | 11.3 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Week 68 | 10.2 percentage of participants |
| Arm B: Ranibizumab | Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time | Baseline | 0 percentage of participants |