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

Neovascular Age-related Macular Degeneration (nAMD) Clinical Trial

— BLUESKY-PT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04764656
• Other study ID #: CRTH258APT02
• Status: Active, not recruiting
• Start date: May 10, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Portugal	Novartis Investigative Site	Funchal
Portugal	Novartis Investigative Site	Leiria
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Santa Maria da Feira
Portugal	Novartis Investigative Site	Tomar

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fluid resolution after initiation of brolucizumab	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	Visual Actuity (VA) change from baseline	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	Baseline, month 24
Secondary	Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	Number of injections and total number of visits	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	Describe the distribution of injection intervals	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	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
Secondary	Discontinuation rate	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24
Secondary	Assess the safety of brolucizumab	Detailed Outcome Measure will be defined in the Statistical Analysis Plan	month 24