Phase 3
Completed N=34
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Source: ClinicalTrials.gov NCT03930641 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration — 0; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03930641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.