Phase 3
Completed N=397
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT04047472 ↗Enrolled (actual)
397
Serious AEs
11.8%
Results posted
Dec 2024
Primary outcomePrimary: Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye — 9.9; 10.9 Letters Read — p=0.006
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye |
9.9; 10.9 | 0.006 sig |
| SECONDARY Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye |
9.7; 11.0 | 0.009 sig |
| SECONDARY q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability |
0.595 | — |
| SECONDARY q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability |
0.860 | — |
| SECONDARY Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit |
30; 47 | — |
| SECONDARY Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye |
3.9; 4.2; 6.1; 6.5; 7.4; 8.4 | — |
| SECONDARY Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye |
8.3; 9.6; 8.9; 10.4 | — |
| SECONDARY Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit |
36; 50; 47; 60; 59; 70 | — |
| SECONDARY Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye |
139; 146; 103; 104; 68; 73 | — |
| SECONDARY Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye |
73; 94; 102; 115; 122; 139 | — |
| SECONDARY Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye |
39; 35; 57; 59; 79; 85 | — |
| SECONDARY Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye |
21; 19; 37; 28; 49; 48 | — |
| SECONDARY Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye |
16; 11; 7; 6; 5; 4 | — |
| SECONDARY Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study |
20; 15; 19; 15; 14; 8 | — |
| SECONDARY Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study |
6; 6; 5; 4; 6; 4 | — |
| SECONDARY Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study |
2; 5; 2; 3; 5; 3 | — |
| SECONDARY Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye |
-181.2; -161.9 | — |
| SECONDARY Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye |
-187.9; -167.2 | — |
| SECONDARY Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye |
-148.5; -132.5; -183.3; -161.8; -193.2; -169.9 | — |
| SECONDARY Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye |
-57.2; -48.3; -65.4; -53.2; -68.6; -53.2 | — |
| SECONDARY Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) |
78; 92; 32; 51; 33; 44 | — |
| SECONDARY Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 |
18; 24; 13; 12; 15; 18 | — |
| SECONDARY Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye |
149; 156; 63; 83; 19; 42 | — |
| SECONDARY Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye |
83; 81; 26; 17; 15; 13 | — |
| SECONDARY Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye |
26; 32; 11; 20; 7; 17 | — |
| SECONDARY Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye |
-1.395; -1.378; -2.034; -1.984 | — |
| SECONDARY Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit |
0; 0; 15; 17; 18; 24 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score |
3.0; 3.7; 4.1; 2.9 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision |
7.7; 7.8; 9.0; 6.4 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain |
0.9; 6.1; 1.0; 3.1 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities |
5.3; 5.8; 8.1; 5.7 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities |
2.2; 4.2; 3.8; 4.8 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning |
1.5; 2.4; 2.3; 0.8 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health |
4.6; 0.6; 4.7; 1.0 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties |
0.5; 3.8; 4.5; 2.7 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency |
3.9; 2.1; 6.6; 0.6 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving |
3.4; 0.8; 3.9; 4.6 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision |
1.3; 2.2; 0.6; 0.5 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision |
1.6; 2.4; 0.5; 1.4 | — |
| SECONDARY Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating |
-3.6; 0.7; -4.4; -2.7 | — |
| SECONDARY Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm |
82; 116 | — |
| SECONDARY Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm |
170; 27 | — |
| SECONDARY Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects |
39.7 | — |
| SECONDARY Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects |
5.25 | — |
| SECONDARY Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects |
2690 | — |
| SECONDARY Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects |
3100 | — |
| SECONDARY Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects |
110 | — |
| SECONDARY Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects |
1.93 | — |
| SECONDARY Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects |
307 | — |
| SECONDARY Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye |
58; 48; 10; 6; 7; 3 | — |
| SECONDARY Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) |
97; 113 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment was performed.
- Male or female Chinese participants ≥ 50 years of age at the time of screening.
- Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at screening and confirmed by the Central Reading Center (CRC).
- Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye at screening and confirmed by the CRC.
- Intra and/or subretinal fluid affecting the central subfield of the study eye at screening and confirmed by the CRC.
- BCVA between 78 and 23 letters, inclusive, in the study eye at screening and baseline using ETDRS testing.
Exclusion Criteria
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at baseline.
- Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at screening and confirmed by the CRC.
- Total area of fibrosis ≥ 50% of the total lesion in the study eye at screening and confirmed by the CRC.
- Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening and confirmed by the CRC.
- Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
- Retinal pigment epithelium rip/tear in the study eye at screening.
- Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.
Data sourced from ClinicalTrials.gov (NCT04047472). 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.