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NCT04764656Terminated

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

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2025

Reason given: The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.

Brief summary (registry, in English)

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

Status (registry)
Terminated
Study type
Observational
Enrollment
81 (actual)
First submitted
19 Feb 2021
Start date
10 May 2021
Primary completion date
16 Feb 2024
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT04764656

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
  • Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
  • 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

Other illness

  • Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
  • Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation

Other

  • 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
  • Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
  • Patients participating in parallel in an interventional clinical trial
  • Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening

Who the study is looking for

  • 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

Age in the registry: 40 years to 110 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-FunchalPortugalUnknown status
-LeiriaPortugalUnknown status
-LisbonPortugalUnknown status
-PortoPortugalUnknown status
-Santa Maria da FeiraPortugalUnknown status
-TomarPortugalUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.