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

ClinicalTrials.gov Identifier: NCT04764656

Novartis Reference Number: CRTH258APT02

Last Update: Dec 06, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Neovascular Age-related Macular Degeneration (nAMD)
Phase 
Not Given
Overall status 
Recruiting
Start date 
May 12, 2021
Completion date 
May 30, 2024
Gender 
All
Age(s)
40 Years - 110 Years (Adult, Older Adult)

Interventions

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.

Eligibility Criteria

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
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

Study Locations

Portugal
Novartis Investigative Site
Recruiting
Leiria, 2410-187
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1600-209
-
Portugal
Novartis Investigative Site
Recruiting
Porto, 4050-115
-
Portugal
Novartis Investigative Site
Recruiting
Santa Maria da Feira, 4520 211
-
Portugal
Novartis Investigative Site
Recruiting
Tomar, 2300-625
-
Portugal

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]