Phase 3
Completed N=295
Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration
Source: ClinicalTrials.gov NCT04264819 ↗Enrolled (actual)
295
Serious AEs
9.5%
Results posted
Nov 2024
Primary outcomePrimary: Number of Patients With no Disease Activity at Week 16 in the Study Eye — 89 Participants
◆ Published Evidence
Established
42citations · ~14 / year
Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration.
Summary
Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.
Linked Publications
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Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With no Disease Activity at Week 16 in the Study Eye |
89 | — |
| SECONDARY Number of Patients With no Disease Activity at Week 48 in the Study Eye |
102 | — |
| SECONDARY Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye |
-79.19; -88.08; -48.87; -66.75 | — |
| SECONDARY Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye |
104; 245; 204; 4; 285; 61 | — |
| SECONDARY Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye |
4; 114; 122; 69; 80 | — |
| SECONDARY Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye |
10; 24; 13; 7; 19; 102 | — |
| SECONDARY Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye |
10; 19; 18; 3; 6; 51 | — |
| SECONDARY Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye |
2.6; 4.1; 4.1; 3.2 | — |
| SECONDARY Summary of Treatment-emergent Adverse Events - Overall |
165; 34; 33; 28; 14; 4 | — |
| SECONDARY Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) |
100; 92; 15; 11; 9; 8 | — |
| SECONDARY Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular |
90 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must provide written informed consent before any study-related procedures are performed.
- Patients must be 50 years of age or older at Screening/Baseline.
Study eye:
- Active CNV lesions secondary to nAMD diagnosed 25 mmHg on medication or according to the Investigator's judgment, at Screening/Baseline.
- Aphakia and/or absence of the posterior capsule in the study eye. Ocular treatments (study eye)
- Patient has received any investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time.
- Previous use of intraocular or periocular of corticosteroids in the study eye within the 6 month period prior to Screening/Baseline.
- Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline.
- History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline:
- Intraocular or refractive surgery.
- Previous panretinal and peripheral laser photocoagulation.
- Previous macular surgery or other intraocular surgical intervention
- Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.
- Previous treatment with investigational drugs.
Data sourced from ClinicalTrials.gov (NCT04264819) and the linked publication. 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.