Phase 4 N=105 Treatment

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)

Bottom Line

View on ClinicalTrials.gov: NCT05269966 ↗

Enrolled (actual)

105

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab. — 67; 50; 45; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Injection Brolucizumab (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2023

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05269966). 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.