Phase 4
Completed N=105
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration (nAMD)
Source: ClinicalTrials.gov NCT05269966 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. — 67; 50; 45; 9 Participants
◆ Published Evidence
Highly cited
1,099citations · ~26 / year
Age-related macular degeneration and blindness due to neovascular maculopathy.
Summary
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Linked Publications (5)
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Age-related macular degeneration and blindness due to neovascular maculopathy.
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Risk factors for age-related macular degeneration: Pooled findings from three continents.
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The prevalence of age-related macular degeneration in Asians: a systematic review and meta-analysis.
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Forecasting age-related macular degeneration through the year 2050: the potential impact of new treatments.
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Age-related macular degeneration revisited--piecing the puzzle: the LXIX Edward Jackson memorial lecture.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. |
67; 50; 45; 9; 31; 3 | — |
| PRIMARY Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term |
3; 3; 2; 1; 1 | — |
| PRIMARY Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab |
3; 3; 0; 3; 0; 0 | — |
| PRIMARY Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab |
50; 48; 13; 10; 9; 7 | — |
| SECONDARY Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye |
10.7; 15.3 | — |
| SECONDARY Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye |
7.0; 15.0 | — |
| SECONDARY Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye |
27; 41; 79; 46; 62; 78 | — |
| SECONDARY Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye |
2; 2; 3; 2; 2; 3 | — |
| SECONDARY Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye |
6.2 | — |
| SECONDARY Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab |
0.2 | — |
| SECONDARY Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab. |
6.2 | — |
| SECONDARY Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks. |
27 | — |
| SECONDARY Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks. |
74; 27; 74 | — |
| SECONDARY Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye |
2; 0; 0; 2; 0; 0 | — |
| SECONDARY Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye |
23; 54; 22; 43; 50; 7 | — |
| SECONDARY Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye |
10; 0; 0; 11; 0; 0 | — |
| SECONDARY Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye |
20; 57; 14; 30; 57; 4 | — |
| SECONDARY Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye |
-106.9; -103.1 | — |
| SECONDARY Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye |
-60.0; -66.5 | — |
Eligibility Criteria
Inclusion Criteria
- Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
- Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
Note: In case where both eyes are affected, data of only one eye ['study eye'] will be recorded. Selection of the eye to be considered for the purpose of the study [referred to as 'study eye'] will be as per the Investigator's discretion.
Exclusion Criteria
- Patients fulfilling any of the following criteria are not eligible for this study:
- Patient having other eye diseases that could compromise the VA.
- Patient with existing or suspected ocular or periocular infection in the study eye.
- Patient with an existing intraocular inflammation (IOI).
- Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
- Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
- Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
Data sourced from ClinicalTrials.gov (NCT05269966) 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.