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Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

NCT05269966 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-03-20

Study results available
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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.

Conditions

  • Neovascular Age-related Macular Degeneration (nAMD)

Interventions

BIOLOGICAL

Injection Brolucizumab

Single-chain antibody fragment (scFv) Brolucizumab 6 mg was administered by Intravitreal (IVT) injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) were performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-08-29
Completion
2023-08-29

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269966 on ClinicalTrials.gov