CompletedPhase 4

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

India105 participantsStarted 2022-03-09

Plain-language 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.

Who can participate

Age range

50 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this Phase 4 trial specifically tracked eye-related side effects of brolucizumab over 56 weeks, what kinds of ocular adverse events were reported, and how might those risks apply to my situation?
2This study has already completed, so are the safety and effectiveness results available, and what do they suggest about how brolucizumab compares to other anti-VEGF injections I might receive for my nAMD?
3Because the trial focused heavily on monitoring adverse events rather than just measuring vision improvement, does that mean there are still open safety questions about brolucizumab that my care team would want to watch closely if I were treated with it?
4Are there other approved treatments for neovascular AMD — like ranibizumab or aflibercept — that have a longer or more established safety record, and how would you weigh those against brolucizumab for someone in my specific condition?
5Since this trial ran injections for 56 weeks, what does a realistic long-term treatment schedule look like for me, and how would you monitor for the kinds of ocular side effects this study was designed to detect?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.

Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.

Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term

Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.

Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab

Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.

Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab

Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.

Trial details

NCT IDNCT05269966

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-29

Results submitted2024-06-20

View on ClinicalTrials.gov More Neovascular Age-related Macular Degeneration (nAMD) trials