Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Completed · Phase 3
Conditions studied: Neovascular Age Related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT03930641
- Run by
- Novartis Pharmaceuticals
- People needed
- 34
- Starts
- 2019-05-23
- Expected to finish
- 2019-07-02
- Last updated by the study team
- 2021-01-05
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
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.
- Other protocol defined inclusion and exclusion criteria may apply.
Where it is running
- Novartis Investigative Site — Altamonte Springs, Florida, United States
- Novartis Investigative Site — Pensacola, Florida, United States
- Novartis Investigative Site — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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