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

NCT04764656 | Terminated

• 1 other identifier: CRTH258APT02
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 11

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.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

Beovu; Brolucizumab; nAMD; non-interventional trial; fluid resolution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Fluid resolution after initiation of brolucizumab

  month 24

• Visual Actuity (VA) change from baseline

  Baseline, month 24

• Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity

  month 24

• Number of injections and total number of visits

  month 24

• Describe the distribution of injection intervals

  month 24

Study Arms (1)

Brolucizumab

Naïve (Patients being the first time treated) and pre-treated patients

Drug: Brolucizumab

Interventions

Brolucizumab DRUG

There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Brolucizumab

Eligibility Criteria

• Age: 40 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
• Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
• 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
• Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
• Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
• Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
• Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
• Patients participating in parallel in an interventional clinical trial
• Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
• 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
• Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Funchal, 00-024, Portugal

Location

Novartis Investigative Site

Leiria, 2410-187, Portugal

Location

Novartis Investigative Site

Lisbon, 1050-078, Portugal

Location

Novartis Investigative Site

Lisbon, 1200-473, Portugal

Location

Novartis Investigative Site

Lisbon, 1500-473, Portugal

Location

Novartis Investigative Site

Lisbon, 1600-209, Portugal

Location

Novartis Investigative Site

Lisbon, 1649-020, Portugal

Location

Novartis Investigative Site

Lisbon, 1990-196, Portugal

Location

Novartis Investigative Site

Porto, 4050-115, Portugal

Location

Novartis Investigative Site

Santa Maria da Feira, 4520 211, Portugal

Location

Novartis Investigative Site

Tomar, 2300-625, Portugal

Location

Related Links

• Results for CRTH258APT02 from the Novartis Clinical Trials Website

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: May 10, 2021
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (11)