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

Primary Purpose

Neovascular Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RTH258
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring brolucizumab 6 mg prefilled syringe PFS, open label study, neovascular age related macular degeneration intravitreal injection IVT, observation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol defined inclusion and exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RTH258

Arm Description

brolucizumab 6 mg in a prefilled syringe

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2019
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03930641
Brief Title
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Official Title
An Open-Label, Single-Arm, Multicenter, Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration to Evaluate the Safety of Brolucizumab 6 mg in Prefilled Syringe
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age Related Macular Degeneration
Keywords
brolucizumab 6 mg prefilled syringe PFS, open label study, neovascular age related macular degeneration intravitreal injection IVT, observation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
study with a single arm: brolucizumab 6 mg PFS
Masking
None (Open Label)
Masking Description
open label study
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RTH258
Arm Type
Experimental
Arm Description
brolucizumab 6 mg in a prefilled syringe
Intervention Type
Drug
Intervention Name(s)
RTH258
Other Intervention Name(s)
brolucizumab
Intervention Description
6 mg in prefilled syringe
Primary Outcome Measure Information:
Title
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Description
The safety is defined as the incidence of ocular and non-ocular adverse events
Time Frame
Up to Day 31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Other protocol defined inclusion and exclusion criteria may apply.
Facility Information:
Facility Name
Novartis Investigative Site
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Novartis Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=556
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

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

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