Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal

Terminated

• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Interventions: Drug: Brolucizumab

• Registration Number: NCT04764656
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.

Detailed Description

Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.

Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-05-10
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Diagnosis of nAMD
2. Male and Female patients with ≥40 years of age at index
3. Receipt of at least one injection of brolucizumab during the recruitment period
4. Signed written informed consent

Exclusion Criteria

1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
3. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at Screening
4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
8. Patients participating in parallel in an interventional clinical trial
9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
11. Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brolucizumab	Brolucizumab	Naïve (Patients being the first time treated) and pre-treated patients

Primary Outcome Measures

Name	Time	Method
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye	month 12	This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes included in the study, analyzed as two independent groups (naïve and switch).

Secondary Outcome Measures

Name	Time	Method
Fluid resolution after initiation of brolucizumab	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Visual Actuity (VA) change from baseline	Baseline, month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of injections and total number of visits	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Describe the distribution of injection intervals	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Discontinuation rate	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Assess the safety of brolucizumab	month 24	Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇹 Tomar, Portugal