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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930641
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is 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 Intervention/treatment Phase
Neovascular Age Related Macular Degeneration Drug: RTH258 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: study with a single arm: brolucizumab 6 mg PFS
Masking: None (Open Label)
Masking Description: open label study
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 23, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RTH258
brolucizumab 6 mg in a prefilled syringe
Drug: RTH258
6 mg in prefilled syringe
Other Name: brolucizumab




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 8 ]
    The safety is defined as the incidence of ocular and non-ocular adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930641


Locations
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United States, Florida
Novartis Investigative Site
Altamonte Springs, Florida, United States, 32701
Novartis Investigative Site
Pensacola, Florida, United States, 32503
United States, Virginia
Novartis Investigative Site
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03930641    
Other Study ID Numbers: CRTH258A2308
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
brolucizumab 6 mg prefilled syringe PFS
open label study
neovascular age related macular degeneration intravitreal injection IVT
observation
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases