Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal (BLUESKY-PT)

Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal

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

Study Overview

• Status: Terminated
• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Intervention / Treatment: Drug: Brolucizumab

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 Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Portugal
  • Funchal, Portugal, 00-024
    • Novartis Investigative Site
  • Leiria, Portugal, 2410-187
    • Novartis Investigative Site
  • Lisboa, Portugal, 1050-078
    • Novartis Investigative Site
  • Lisboa, Portugal, 1200-473
    • Novartis Investigative Site
  • Lisboa, Portugal, 1500-473
    • Novartis Investigative Site
  • Lisboa, Portugal, 1600-209
    • Novartis Investigative Site
  • Lisboa, Portugal, 1649-020
    • Novartis Investigative Site
  • Lisboa, Portugal, 1990-196
    • Novartis Investigative Site
  • Porto, Portugal, 4050-115
    • Novartis Investigative Site
  • Santa Maria da Feira, Portugal, 4520 211
    • Novartis Investigative Site
  • Tomar, Portugal, 2300-625
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include an estimated number of 120 naïve patients and 180 switch patients with a diagnosis of nAMD being treated with brolucizumab in private clinics in Portugal during the recruitment period

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brolucizumab; Naïve (Patients being the first time treated) and pre-treated patients	Drug: Brolucizumab; There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye	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).	month 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRTH258APT02 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: non-interventional trial; fluid resolution; nAMD; Beovu; Brolucizumab
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CRTH258APT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO