NCT03930641

Brief Summary

This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2020

Completed
Last Updated

January 5, 2021

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

April 26, 2019

Results QC Date

June 23, 2020

Last Update Submit

December 11, 2020

Conditions

Neovascular Age Related Macular Degeneration

Keywords

brolucizumab 6 mg prefilled syringe PFSopen label studyneovascular age related macular degeneration intravitreal injection IVTobservation

Outcome Measures

Primary Outcomes (1)

  • The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

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

    Up to Day 31

Study Arms (1)

RTH258

EXPERIMENTAL

brolucizumab 6 mg in a prefilled syringe

Drug: RTH258

Interventions

RTH258DRUG

6 mg in prefilled syringe

Also known as: brolucizumab
RTH258

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed.
  • Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.
  • Subjects \>= 50 years of age.

You may not qualify if:

  • Active infection or inflammation in the eyes.
  • Uncontrolled glaucoma.
  • History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered.
  • Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment.
  • The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment.
  • Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation.
  • Uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Altamonte Springs, Florida, 32701, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32503, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23235, United States

Location

Related Links

MeSH Terms

Interventions

brolucizumab

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Masking Details
open label study
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: study with a single arm: brolucizumab 6 mg PFS
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 29, 2019

Study Start

May 23, 2019

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

January 5, 2021

Results First Posted

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com

Locations

US(3)