Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema (BLUE SKY)

Novartis

Status: Active, not recruiting

Conditions: Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME)

Treatments: Drug: brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04543331

CRTH258ADE02

Details and patient eligibility

About

This study is a prospective, non-interventional, multicenter, open-label study in nAMD and DME patients being treated with brolucizumab according to the EU SmPC.

An observational study design, without a strict, mandated visit schedule or mandated treatment regimen was chosen as the most appropriate to collect available data in a real life setting. For that reason, this NIS does not impose a therapy protocol, diagnostic/therapeutic procedure or a visit schedule. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care and will take place as per investigator's discretion. This includes e.g. visit frequency, injection frequency and types of assessments performed - only data from routine medical practice will be collected as part of the study.

Full description

BLUE SKY consists of the nAMD-related module BIRL (Brolucizumab In Real Life) and two general, indication-related study modules "BLUE SKY AMD" and "BLUE SKY DME".

Patients will be enrolled at approximately 55 centers, which will be representatively distributed amongst the 16 German federal states. This will ensure to reflect all state-specific health insurance laws and guidelines. Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.

All patients will be documented either in the AMD or DME-module (Full Analysis Set).

For the BIRL module, only naïve nAMD patients enrolled in approximately 7 selected centers will be documented. All these centers are equipped with the Zeiss PlexElite OCT-A, needed to assess and analyze BIRL specific objectives in a comparable setting. Only images from routine medical practice will be collected as part of the study. 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 VA will be chosen as the study eye (if VA is measured equal, the treating ophthalmologist defines the study eye upon his discretion).

The prospective observation period per patient will be up to 24 months.

Enrollment: 573 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The unit of analysis is patient-eye, i.e. all criteria should be applied to the study eye, unless otherwise specified. Patients will be included in the study if they fulfil the following requisites:

1. Diagnosis of nAMD or visual impairment due to DME
2. Male and Female nAMD and DME patients with ≥18 years of age at index
3. Decision to treat with brolucizumab at baseline visit
4. Signed written informed consent
5. Patients for whom a therapy with brolucizumab is medically indicated
6. Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening

Exclusion criteria

1. Patients that have any contraindication or are not eligible for treatment with brolucizumab as according to the SmPC
2. Patients treated for RVO or CNV other than nAMD
3. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
4. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion (nAMD)
5. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
6. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
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. Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3-month period prior to baseline
11. Prior use of intraocular or periocular corticosteroids in the study eye provided at least 4 months prior to baseline
12. Pregnancy and breast-feeding

Trial design

573 participants in 2 patient groups

treatment naïve patients

Description:

Patients being the first time treated for nAMD or DME

Treatment:

Drug: brolucizumab

pre-treated patients

Description:

Patients already being treated for nAMD or DME

Treatment:

Drug: brolucizumab