TerminatedNot Applicable

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

Stopped: 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.

Portugal81 participantsStarted 2021-05-10

Plain-language 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.

Who can participate

Age range40 Years – 110 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye

Timeframe: month 12

Trial details

NCT IDNCT04764656

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-16

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