Trial Outcomes & Findings for Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection (NCT NCT02713204)

Last Updated: 2019-05-07

Results Overview

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

365 participants

Primary outcome timeframe

At Week 12

Results posted on

2019-05-07

Participant Flow

The study was conducted at 87 sites in the United States. A total of 560 participants were screened in the study.

Out of 560 participants, 365 were randomized \& treated. Participants were randomized in 1:2:3 to receive REGN910-3 3:2mg, REGN910-3 6:2mg \& 2mg intravitreal aflibercept injection (IAI) followed by re-randomization at week 12 in REGN910-3 6:2mg \& IAI 2mg arm. Not all participants who completed Week 12 were re-randomized \& continued to Week 36.

Participant milestones

Participant milestones
Measure	REGN910-3 (3 mg:2 mg) Participants were administered intravitreal injection of REGN910-3 (3 milligram \[mg\]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept 2 mg Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32.	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI Q8 beginning at week 16 through week 32.	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
Baseline (Day 1) up to Week 12 STARTED	60	122	183	0	0	0	0	0
Baseline (Day 1) up to Week 12 COMPLETED	59	121	181	0	0	0	0	0
Baseline (Day 1) up to Week 12 NOT COMPLETED	1	1	2	0	0	0	0	0
From Week 12 up to Week 36 STARTED	58	0	0	57	62	60	62	58
From Week 12 up to Week 36 COMPLETED	57	0	0	53	60	59	60	54
From Week 12 up to Week 36 NOT COMPLETED	1	0	0	4	2	1	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	REGN910-3 (3 mg:2 mg) Participants were administered intravitreal injection of REGN910-3 (3 milligram \[mg\]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept 2 mg Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q12 beginning at Week 20 through Week 32.	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive IAI Q8 beginning at week 16 through week 32.	Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
Baseline (Day 1) up to Week 12 Adverse Event	1	0	1	0	0	0	0	0
Baseline (Day 1) up to Week 12 Withdrawal by Subject	0	0	1	0	0	0	0	0
Baseline (Day 1) up to Week 12 Lost to Follow-up	0	1	0	0	0	0	0	0
From Week 12 up to Week 36 Adverse Event	1	0	0	1	1	0	2	1
From Week 12 up to Week 36 Death	0	0	0	1	0	1	0	3
From Week 12 up to Week 36 Lost to Follow-up	0	0	0	2	0	0	0	0
From Week 12 up to Week 36 Participant Re-located	0	0	0	0	1	0	0	0

Baseline Characteristics

Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REGN910-3 (3 mg:2 mg) n=59 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=122 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 or Week 20 and Q8 or Q12 through Week 32.	Aflibercept (IAI) 2 mg n=183 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Total n=364 Participants Total of all reporting groups
Age, Continuous	79.2 years STANDARD_DEVIATION 9.37 • n=5 Participants	79.4 years STANDARD_DEVIATION 8.91 • n=7 Participants	78.4 years STANDARD_DEVIATION 8.37 • n=5 Participants	78.9 years STANDARD_DEVIATION 8.71 • n=4 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	75 Participants n=7 Participants	110 Participants n=5 Participants	226 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	47 Participants n=7 Participants	73 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	115 Participants n=7 Participants	174 Participants n=5 Participants	346 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	58 Participants n=5 Participants	116 Participants n=7 Participants	178 Participants n=5 Participants	352 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA \& at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here "Overall Number of Participants Analyzed" = Participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=59 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=122 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=183 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12	—	—	5.2 Letters correctly read Standard Deviation 10.51	5.6 Letters correctly read Standard Deviation 10.59	5.4 Letters correctly read Standard Deviation 9.85	—

PRIMARY outcome

Timeframe: At Week 36

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=58 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=60 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36	4.2 Letters correctly read Standard Deviation 12.50	2.9 Letters correctly read Standard Deviation 12.16	5.9 Letters correctly read Standard Deviation 11.95	6.0 Letters correctly read Standard Deviation 12.00	6.4 Letters correctly read Standard Deviation 12.24	6.9 Letters correctly read Standard Deviation 12.49

SECONDARY outcome

Timeframe: At Week 12

Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=59 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=122 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=182 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12	—	—	-182.2 Microns Standard Deviation 172.73	-200.0 Microns Standard Deviation 152.82	-178.6 Microns Standard Deviation 138.85	—

SECONDARY outcome

Timeframe: At Week 36

Population: FAS secondary randomization set was used. Here "Overall Number of Participants Analyzed"= Participants who were evaluable for this endpoint.

CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=58 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=59 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36	-169.7 Microns Standard Deviation 129.74	-187.3 Microns Standard Deviation 161.72	-174.6 Microns Standard Deviation 165.22	-216.6 Microns Standard Deviation 187.40	-181.3 Microns Standard Deviation 148.71	-198.4 Microns Standard Deviation 155.72

SECONDARY outcome

Timeframe: At Week 12

Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=115 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=171 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12	—	—	-2.2 mm^2 Standard Deviation 5.59	-3.5 mm^2 Standard Deviation 5.34	-3.7 mm^2 Standard Deviation 6.22	—

SECONDARY outcome

Timeframe: At Week 36

Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=58 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=56 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=59 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36	-5.1 mm^2 Standard Deviation 5.60	-5.3 mm^2 Standard Deviation 5.19	-3.7 mm^2 Standard Deviation 5.04	-4.1 mm^2 Standard Deviation 6.09	-4.9 mm^2 Standard Deviation 5.58	-4.3 mm^2 Standard Deviation 6.55

SECONDARY outcome

Timeframe: At Week 12

Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=115 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=171 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Total Lesion Area at Week 12	—	—	-2.0 mm^2 Standard Deviation 6.10	-3.5 mm^2 Standard Deviation 5.45	-3.4 mm^2 Standard Deviation 6.48	—

SECONDARY outcome

Timeframe: At Week 36

Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=58 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=56 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=59 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Change From Baseline in Total Lesion Area at Week 36	-4.7 mm^2 Standard Deviation 5.43	-5.3 mm^2 Standard Deviation 5.20	-3.0 mm^2 Standard Deviation 5.91	-3.9 mm^2 Standard Deviation 5.79	-4.7 mm^2 Standard Deviation 5.35	-3.9 mm^2 Standard Deviation 6.67

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 12

Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on optical coherence tomography (OCT). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=122 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=179 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12	—	—	0.49 Proportion of participants	0.51 Proportion of participants	0.44 Proportion of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 36

Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on OCT. If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=55 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=59 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36	0.53 Proportion of participants	0.47 Proportion of participants	0.54 Proportion of participants	0.49 Proportion of participants	0.53 Proportion of participants	0.42 Proportion of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Week 36

Kaplan-Meier estimated time to no retinal and/or subretinal fluid through week 36 (days). Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.

Outcome measures

Outcome measures
Measure	Aflibercept (IAI) 2 mg Q4 to Aflibercept (IAI) 2 mg Q12 n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q12 beginning at Week 20 through Week 32.	Aflibercept (IAI) 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 n=58 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	REGN910-3 (3 mg:2 mg) n=58 Participants Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 (6 mg:2 mg) n=57 Participants Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	Aflibercept (IAI) 2 mg n=62 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	Aflibercept 2(IAI) mg Q4 to Aflibercept (IAI) 2 mg Q8 n=60 Participants Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 beginning at Week 16 through Week 32.
Time to No Retinal and/or Subretinal Fluid Through Week 36	96.5 Days Standard Error 11.27	107.1 Days Standard Error 10.05	105.6 Days Standard Error 11.06	80.9 Days Standard Error 9.02	84.9 Days Standard Error 8.01	106.4 Days Standard Error 11.04

Adverse Events

REGN910-3 3 mg:2 mg

Serious events: 11 serious events

Other events: 17 other events

Deaths: 1 deaths

REGN910-3 6 mg:2 mg

Serious events: 20 serious events

Other events: 41 other events

Deaths: 2 deaths

IAI 2 mg

Serious events: 30 serious events

Other events: 51 other events

Deaths: 7 deaths

IAI 2mg to REGN910-3

Serious events: 8 serious events

Other events: 20 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	REGN910-3 3 mg:2 mg n=60 participants at risk Participants were administered intravitreal injection of REGN910-3 (3 mg:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 through Week 32.	REGN910-3 6 mg:2 mg n=122 participants at risk Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.	IAI 2 mg n=183 participants at risk Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.	IAI 2mg to REGN910-3 n=58 participants at risk Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. Data in this arm include only the 58 participants that switched to high dose at week 16. Data from these 58 participants are also included in the Aflibercept (IAI) 2 mg arm (n = 183).
Cardiac disorders Atrial fibrillation	5.0% 3/60 • Number of events 3 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.6% 2/122 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	2.2% 4/183 • Number of events 5 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.7% 1/58 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Eye disorders Dry eye	3.3% 2/60 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	5.7% 7/122 • Number of events 8 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	2.2% 4/183 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.7% 1/58 • Number of events 1 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Eye disorders Neovascular age-related macular degeneration	6.7% 4/60 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	4.1% 5/122 • Number of events 5 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	2.7% 5/183 • Number of events 5 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	0.00% 0/58 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Eye disorders Retinal haemorrhage	0.00% 0/60 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.6% 2/122 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	6.6% 12/183 • Number of events 14 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	10.3% 6/58 • Number of events 7 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Eye disorders Vitreous detachment	5.0% 3/60 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	5.7% 7/122 • Number of events 7 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	2.2% 4/183 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.7% 1/58 • Number of events 1 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Infections and infestations Upper respiratory tract infection	6.7% 4/60 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.6% 2/122 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.6% 3/183 • Number of events 3 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	3.4% 2/58 • Number of events 2 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Infections and infestations Urinary tract infection	0.00% 0/60 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	5.7% 7/122 • Number of events 7 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	3.3% 6/183 • Number of events 7 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.7% 1/58 • Number of events 1 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Vascular disorders Hypertension	6.7% 4/60 • Number of events 4 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	10.7% 13/122 • Number of events 15 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	9.3% 17/183 • Number of events 18 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	13.8% 8/58 • Number of events 9 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.7% 1/60 • Number of events 1 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	0.82% 1/122 • Number of events 1 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	1.6% 3/183 • Number of events 3 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).	5.2% 3/58 • Number of events 3 • Timeframe for AE reporting Reported adverse events are treatment-emergent adverse events that are AEs that developed/worsened during the study (Baseline through Week 36).

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER