BLUESKY-PT: Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04764656

Collaborator

(none)

300

Enrollment

Locations

43.6

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration (nAMD)	Drug: Brolucizumab

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Brolucizumab Naïve (Patients being the first time treated) and pre-treated patients	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.

Arm

Intervention/Treatment

Brolucizumab

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

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.

Outcome Measures

Primary Outcome Measures

Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye [month 12]
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).

Secondary Outcome Measures

Fluid resolution after initiation of brolucizumab [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Visual Actuity (VA) change from baseline [Baseline, month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of injections and total number of visits [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Describe the distribution of injection intervals [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF) [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Discontinuation rate [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Assess the safety of brolucizumab [month 24]
Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Funchal	Portugal	00-024
2	Novartis Investigative Site	Leiria	Portugal	2410-187
3	Novartis Investigative Site	Lisboa	Portugal	1050-078
4	Novartis Investigative Site	Lisboa	Portugal	1050-085
5	Novartis Investigative Site	Lisboa	Portugal	1200-473
6	Novartis Investigative Site	Lisboa	Portugal	1500-473
7	Novartis Investigative Site	Lisboa	Portugal	1600-209
8	Novartis Investigative Site	Lisboa	Portugal	1649-020
9	Novartis Investigative Site	Lisboa	Portugal	1990-196
10	Novartis Investigative Site	Porto	Portugal	4050-115
11	Novartis Investigative Site	Santa Maria da Feira	Portugal	4520 211
12	Novartis Investigative Site	Tomar	Portugal	2300-625