An observational study in Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME), sponsored by Novartis Pharmaceuticals. Completed at 41 sites in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients being treated for nAMD or DME with brolucizumab will be enrolled in the study upon signing an informed consent.
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:
Exclusion Criteria:
Patients being the first time treated for nAMD or DME
Drug: brolucizumab
Patients already being treated for nAMD or DME
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.
Percentage of patients' eyes that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF)
This outcome measure is part of the BLUE SKY AMD module. This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes, analyzed as two independent groups (naïve and switch).
Time frame: Month 12
Mean change in visual actuity (VA) under clinic specific routine treatment schemes
This outcome measure is part of the BIRL module. This primary study objective will be addressed considering treatment naïve patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eye.
Time frame: Baseline, month 12
Morphological CNV-Changes under clinic specific routine treatment schemes
This outcome measure is part of the BIRL module. This primary study objective will be addressed considering treatment naïve patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eye.
Time frame: Baseline, month 12
Percent of patients maintained on q12w dosing after loading through Week 52
This outcome measure is part of the BLUE SKY DME module. This primary study objective will be addressed considering treatment naïve patient eyes included in the study.
Time frame: After loading, month 12
Change in interval length from last interval before switch (baseline) to last interval at end of follow-up (12 months)
This outcome measure is part of the BLUE SKY DME module. This primary study objective will be addressed considering pre-treated patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes.
Time frame: Baseline, month 12
Characterize nAMD patients who initiated treatment with brolucizumab with the respect to baseline characteristics
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Baseline
Evaluate anatomical parameters during treatment with brolucizumab
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan.
Time frame: Up to month 24
Evaluate VA change from baseline during treatment with brolucizumab
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan.
Time frame: Baseline, month 24
Estimate number of anti-VEGF injections, visits and injection intervals
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Estimate percentage of switchers during first 6 months and characterize switchers
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Baseline, month 6
Estimate discontinuation rate and time to discontinuation
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 1-12 and 13-24
Assess retreatment criteria
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Estimate the number of OCT
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 1-12 and 13-24
Assess the safety of brolucizumab
nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Evaluate anatomical effectiveness
naive nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Evaluate treatment intervals
naive nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Describe implementation of treatment schemes into clinical practice
naive nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Evaluate morphological changes under brolucizumab treatment using multimodal imaging
naive nAMD patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Percentage of patient's eyes with absence of IRF and/or SRF at month 12 (naive and switch)
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 12
Evaluate anatomical parameters during treatment with brolucizumab
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 1-12 and 13-24
Characterize VA change from baseline during treatment with brolucizumab
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 1-12 and 13-24
Estimate discontinuation rate during first year of brolucizumab treatment
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Baseline, month 12
Estimate time to discontinuation (persistence)
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Up to month 24
Estimate the treatment burden
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Month 1-12 and 13-24
Estimate the number of OCT and the number of visits with/without OCT
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan.
Time frame: Month 1-12 and 13-24
Assess safety of brolucizumab
DME patients. Detailed Outcome Measure will be defined in the Statistical Analysis Plan.
Time frame: Up to month 24
Plan to share: No
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Novartis Pharmaceuticals