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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03930641

Recruitment Status Completed

First Posted April 29, 2019

Result First Posted July 10, 2020

Last update posted October 2, 2020

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.

  • Condition or Disease:Neovascular Age Related Macular Degeneration
  • Intervention/Treatment: Drug: RTH258
  • Phase: Phase 3
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 34 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: study with a single arm: brolucizumab 6 mg PFS
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
Experimental: RTH258
brolucizumab 6 mg in a prefilled syringe
Drug: RTH258
6 mg in prefilled syringe
Outcome Measures
  • Primary Outcome Measures: 1. The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration [ Time Frame: Up to Day 31 ]
    The safety is defined as the incidence of ocular and non-ocular adverse events
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, Florida
Novartis Investigative Site
Altamonte Springs

United States, Florida
Novartis Investigative Site
Pensacola

United States, Virginia
Novartis Investigative Site
Richmond

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information
  • Responsible Party: Novartis Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03930641 History of Changes
  • Other Study ID Numbers: CRTH258A2308
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: October 2, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Novartis Pharmaceuticals: brolucizumab 6 mg prefilled syringe PFS
    open label study
    neovascular age related macular degeneration intravitreal injection IVT
    observation
  • Additional relevant MeSH terms: Macular Degeneration Wet Macular Degeneration
  • Study Type: Interventional
  • Study Design: Allocation: N/A;Intervention Model: Single Group Assignment;Masking: None (Open Label);Primary Purpose: Treatment
  • Condition: Neovascular Age Related Macular Degeneration
  • Interventions : Drug: RTH258
  • Enrollment: 34
Participant flow
Recruitment Details Thirty-five subjects were enrolled and 34 received one IVT injection of brolucizumab 6 mg PFS. One subject withdrew consent before receiving treatment.
Pre-assignment Details
Arm/Group title RTH258
Arm/Group Description Brolucizumab 6 mg in a prefilled syringe
Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Reason Not Completed
Baseline Characteristics
Arm/Group title RTH258
Arm/Group Description Brolucizumab 6 mg in a prefilled syringe
Overall Number of Baseline Participants 34
Baseline Analysis Population Description [Not Specified]
Outcome Measures
1. PrimaryOutcome
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
Outcome Measure Data
Analysis Population Description
Full Analysis Set
 
Arm/Group title RTH258
Arm/Group Description Brolucizumab 6 mg in a prefilled syringe
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
Deaths
Adverse Events
Adverse Events
Time Frame Adverse events were collected from first dose of study treatment until end of study treatment plus 30 post treatment, up to maximum duration of approximately two months.
Adverse Event Reporting Description Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Normal reporting of treatment emergent AEs which are not SAEs are normally reported with an incidence greater than or equal to 5%.
 
Arm/Group Title RTH258
Arm/Group Description Brolucizumab 6 mg in a prefilled syringe
All-Cause Mortality
  RTH258
Affected at Risk (%)
Total 0/34 (0.00%)
Total
Total, all-cause mortality 0 /34 (0.00%)
Serious Adverse Events
  RTH258
Affected at Risk (%)
Total 0/34 (0.00%)
Total
Total, serious adverse events 0 /34 (0.00%)
Show Other (Not Including Serious) Adverse Events
  RTH258
Affected at Risk (%)
Total 0/34 (0.00%)
Total
Total, other adverse events 0 /34 (0.00%)
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact
  • ClinicalTrials.gov Identifier: NCT03930641 History of Changes
  • Other Study ID Numbers: CRTH258A2308
  • First Submitted: April 26, 2019
  • First Posted: April 29, 2019
  • Results First Submitted: June 23, 2020
  • Results First Posted: July 10, 2020
  • Last Update Posted: October 2, 2020