Trial Outcomes & Findings for Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration (NCT NCT03930641)

NCT ID: NCT03930641

Last Updated: 2021-01-05

Results Overview

The safety is defined as the incidence of ocular and non-ocular adverse events

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Up to Day 31

Results posted on

2021-01-05

Participant Flow

Thirty-five subjects were enrolled and 34 received one IVT injection of brolucizumab 6 mg PFS. One subject withdrew consent before receiving treatment.

Participant milestones

Participant milestones
Measure	RTH258 Brolucizumab 6 mg in a prefilled syringe
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RTH258 n=34 Participants Brolucizumab 6 mg in a prefilled syringe
Age, Continuous	76.9 Years STANDARD_DEVIATION 9.14 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 31

Population: Full Analysis Set

The safety is defined as the incidence of ocular and non-ocular adverse events

Outcome measures

Outcome measures
Measure	RTH258 n=34 Participants Brolucizumab 6 mg in a prefilled syringe
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration Adverse Events	0 Participants
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration Deaths	0 Participants

Adverse Events

RTH258

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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