Trial Outcomes & Findings for A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD) (NCT NCT04450329)

NCT ID: NCT04450329

Last Updated: 2024-02-05

Results Overview

The VA was assessed using original series ETDRS charts or 2702 series number charts.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

449 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2024-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	SB15 (Proposed Aflibercept Biosimilar) Subjects who were randomized at Week 0 to receive SB15 (Aflibercept) every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by once every 8 weeks until Week 32. After re-randomization at Week 32, all the subjects continued to receive SB15 once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by once every 8 weeks until Week 32. After re-randomization at Week 32, subjects were transitioned to SB15 or Eylea 2mg (0.05 mL) once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) to SB15 Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) in the Main Period, and after re-randomization at Week 32, transitioned to receive SB15 (Aflibercept) once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) to Eylea Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) in the Main Period, and after re-randomization at Week 32, continued to receive Eylea once every 8 weeks in transition period (Week 32 to Week 48).
Main Period STARTED	224	225	0	0
Main Period COMPLETED	219	219	0	0
Main Period NOT COMPLETED	5	6	0	0
Transition Period STARTED	219	0	111	108
Transition Period COMPLETED	215	0	109	101
Transition Period NOT COMPLETED	4	0	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SB15 (Proposed Aflibercept Biosimilar) n=224 Participants Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. SB15 (Proposed aflibercept biosimilar): Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.	Eylea (Aflibercept) n=225 Participants Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48. SB15 (Proposed aflibercept biosimilar): Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks. Eylea (Aflibercept): Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.	Total n=449 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical >=65 years	191 Participants n=5 Participants	202 Participants n=7 Participants	393 Participants n=5 Participants
Age, Continuous	73.7 years STANDARD_DEVIATION 8.05 • n=5 Participants	74.3 years STANDARD_DEVIATION 8.09 • n=7 Participants	74.0 years STANDARD_DEVIATION 8.07 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	132 Participants n=7 Participants	250 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	93 Participants n=7 Participants	199 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	170 Participants n=5 Participants	172 Participants n=7 Participants	342 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Primary outcome was analyzed on 448 subjects who were randomised at Week 0 in a 1:1 ratio to either SB15 or Eylea. Among 449 randomised subjects at Week 0, one subject in Eylea group did not receive IP during the study and was excluded from the analysis as pre-specified in analysis plan.

The VA was assessed using original series ETDRS charts or 2702 series number charts.

Outcome measures

Outcome measures
Measure	SB15 (Proposed Aflibercept Biosimilar) n=224 Participants Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. SB15 (Proposed aflibercept biosimilar): Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.	Eylea (Aflibercept) n=224 Participants Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48. SB15 (Proposed aflibercept biosimilar): Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks. Eylea (Aflibercept): Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
Change From Baseline in Best Corrected Visual Acuity (BCVA)	6.7 letters Standard Error 0.56	6.6 letters Standard Error 0.57

Adverse Events

SB15 (Proposed Aflibercept Biosimilar)

Serious events: 22 serious events

Other events: 33 other events

Deaths: 1 deaths

Eylea (Aflibercept)

Serious events: 27 serious events

Other events: 23 other events

Deaths: 2 deaths

Eylea (Aflibercept) to SB15

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Eylea (Aflibercept) to Eylea

Serious events: 13 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	SB15 (Proposed Aflibercept Biosimilar) n=224 participants at risk Subjects who were randomized at Week 0 to receive SB15 (Aflibercept) every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by once every 8 weeks until Week 32. After re-randomization at Week 32, all the subjects continued to receive SB15 once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) n=224 participants at risk Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by once every 8 weeks until Week 32. After re-randomization at Week 32, subjects were transitioned to SB15 or Eylea 2mg (0.05 mL) once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) to SB15 n=111 participants at risk Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) in the Main Period, and after re-randomization at Week 32, transitioned to receive SB15 (Aflibercept) once every 8 weeks in transition period (Week 32 to Week 48).	Eylea (Aflibercept) to Eylea n=104 participants at risk Subjects who were randomized at Week 0 to receive Eylea (Aflibercept) in the Main Period, and after re-randomization at Week 32, continued to receive Eylea once every 8 weeks in transition period (Week 32 to Week 48).
Eye disorders Neovascular age-related macular degeneration	8.0% 18/224 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	6.2% 14/224 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	9.0% 10/111 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	3.8% 4/104 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.
Eye disorders Visual acuity reduced	6.7% 15/224 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	4.9% 11/224 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	5.4% 6/111 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.	3.8% 4/104 • Overall Period (56 weeks) Safety analysis was performed on subjects who received at least one IP during the study period. Among 224 and 225 subjects initially randomised to SB15 and Eylea group, each of 224 and 224 subjects received the IP on Day 1. Safety analysis after Week 32 was performed on subjects who received at least one IP after re-randomisation. Among 111 and 108 subjects re-randomised to "Eylea to SB15" and "Eylea to Eylea" group, each of 111 and 104 subjects received at least one IP after Week 32.

Additional Information

Director of Clinical Trials

Samsung Bioepis Co., Ltd

Phone: +82-32-728-0371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place