Trial Outcomes & Findings for A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (NCT NCT05704725)

Last Updated: 2025-02-14

Results Overview

A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

Day of IVT injection (study day 1)

Results posted on

2025-02-14

Participant Flow

This study was conducted at 4 centers in the United States between 23 January 2023 and 24 March 2023.

Participants were randomized in a ratio of 2:1 to receive either a single intravitreal (IVT) injection of ABP 938 in a pre-filled syringe (PFS) or a single injection of aflibercept in a PFS.

Participant milestones

Participant milestones
Measure	ABP 938 Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Overall Study STARTED	33	16
Overall Study COMPLETED	32	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABP 938 Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABP 938 n=33 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.	Total n=49 Participants Total of all reporting groups
Age, Continuous	71.0 Years STANDARD_DEVIATION 11.40 • n=5 Participants	66.3 Years STANDARD_DEVIATION 15.64 • n=7 Participants	69.5 Years STANDARD_DEVIATION 12.97 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	2 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	14 Participants n=7 Participants	42 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of IVT injection (study day 1)

Population: FAS (only participants with available data are included.)

Outcome measures

Outcome measures
Measure	ABP 938 n=32 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Percentage of IVT Injections Successfully Administered	100 Percentage of Successful Injections Interval 89.1 to 100.0	100 Percentage of Successful Injections Interval 79.4 to 100.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: Safety Analysis Set (SAS): all randomized participants who received investigational product.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. Events that met the AE definition are as follows: * Any abnormal or worsening ocular safety result that is considered clinically significant in the medical and scientific judgment of the investigator. * Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. * New conditions detected or diagnosed after study treatment administration even though it may have been present before the start of the study. * Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a concomitant medication. AEs were classified by system organ class (SOC) according to the Medical Dictionary for Regulatory Activities (medDRA) and graded by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Outcome measures

Outcome measures
Measure	ABP 938 n=32 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: SAS

A serious AE is any event that met at least 1 of the following serious criteria: * Fatal. * Life-threatening (places the participant at immediate risk of death). * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Congenital anomaly/birth defect. * Other medically important serious event. AEs were classified by SOC according to medDRA and graded by CTCAE, version 5.0

Outcome measures

Outcome measures
Measure	ABP 938 n=32 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Number of Participants With Serious Ocular TEAEs in Study Eye	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: SAS

Outcome measures

Outcome measures
Measure	ABP 938 n=32 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 Participants Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Number of Participants With Non-ocular Serious TEAEs	0 Participants	0 Participants

Adverse Events

ABP 938

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Aflibercept

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ABP 938 n=32 participants at risk Participants received a single 2.0 mg/0.05 mL IVT injection of ABP 938 by PFS.	Aflibercept n=16 participants at risk Participants received a single 2.0 mg/0.05 mL IVT injection of aflibercept by PFS.
Eye disorders Vitreous detachment	6.2% 2/32 • 28 days	0.00% 0/16 • 28 days
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • 28 days	6.2% 1/16 • 28 days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/32 • 28 days	6.2% 1/16 • 28 days

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER