Trial Outcomes & Findings for Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe (NCT NCT05161806)

Results Overview

Number of participants with ocular treatment emergent adverse events were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

throughout the study, approximately 31 days

Results posted on

2022-11-18

Participant Flow

Study was conducted in 3 study sites in the US. All 3 sites screened and treated participants.

All enrolled participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL).

Participant milestones

Participant milestones
Measure	SOK583A1 (40 mg/mL) participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study
Overall Study STARTED	30
Overall Study Full Analysis Set (FAS)	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOK583A1 (40 mg/mL) n=30 Participants participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study
Age, Continuous	79.4 Years STANDARD_DEVIATION 7.41 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: throughout the study, approximately 31 days

Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.

Number of participants with ocular treatment emergent adverse events were reported.

Outcome measures

Outcome measures
Measure	SOK583A1 (40 mg/mL) n=30 Participants participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study
Number of Participants With Ocular Treatment Emergent Adverse Events	2 Participants

PRIMARY outcome

Timeframe: throughout the study, approximately 31 days

Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.

Number of participants with non ocular Treatment emergent adverse events were reported.

Outcome measures

Outcome measures
Measure	SOK583A1 (40 mg/mL) n=30 Participants participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study
Number of Participants With Non-ocular Treatment Emergent Adverse Events	1 Participants

Adverse Events

SOK583A1 (40 mg/mL)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SOK583A1 (40 mg/mL) n=30 participants at risk participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study
Eye disorders Foreign body sensation in eyes	3.3% 1/30 • Adverse events were collected throughout the study i.e. approximately 31 days Any signs or symptoms were collected throughout the study i.e. approximately 31 days
Investigations Intraocular pressure increased	3.3% 1/30 • Adverse events were collected throughout the study i.e. approximately 31 days Any signs or symptoms were collected throughout the study i.e. approximately 31 days
Vascular disorders Hypertension	3.3% 1/30 • Adverse events were collected throughout the study i.e. approximately 31 days Any signs or symptoms were collected throughout the study i.e. approximately 31 days
Eye disorders Ocular discomfort	3.3% 1/30 • Adverse events were collected throughout the study i.e. approximately 31 days Any signs or symptoms were collected throughout the study i.e. approximately 31 days

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER