BLUE SKY: Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04543331

Collaborator

(none)

600

Enrollment

Locations

48.1

Anticipated Duration (Months)

12.8

Patients Per Site

0.3

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 nAMD patients being treated for nAMD with brolucizumab according to the 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.

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

Detailed Description

BLUE SKY consists of the two main study modules DEEP BLUE (Observational stuDy to Evaluate fluid resolution and Effectiveness in Patients receiving Beovu (broLUcizumab) in neovascular age-related macular dEgeneration) and BIRL (Brolucizumab In Real Life).

Patients will be enrolled at approximately 32 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. Out of the patients, 1/3 should be pre-treated and 2/3 naïve. All patients will be documented for the DEEP BLUE study module (Full Analysis Set).

For the BIRL module, only naïve patients enrolled in 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 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 prospective observation period per patient will be up to 24 months.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

OBservationaL stUdy to Evaluate Fluid reSolution and Effectiveness in Patients Receiving Beovu (Brolucizumab) Under KeY Treatment Schemes in Neovascular Age-related Macular Degeneration

Actual Study Start Date :

Nov 5, 2020

Anticipated Primary Completion Date :

Nov 7, 2024

Anticipated Study Completion Date :

Nov 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
treatment naïve patients Patients being the first time treated for nAMD	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.
pre-treated patients Patients already being treated for nAMD	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

treatment naïve patients

Patients being the first time treated for nAMD

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.

pre-treated patients

Patients already being treated for nAMD

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 Oucome Measure is part of the Deep Blue module. 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).
Mean change in visual actuity (VA) in the study eye considering treatment naïve subgroup [Baseline, month 12]
Mean change in visual actuity (VA) under clinic specific routine treatment schemes Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes. BIRL module
Morphological CNV-Changes in the study eye considering treatment naïve subgroup [Baseline, month 12]
Morphological Choroidal Neovascularization (CNV)-Changes under clinic specific routine treatment schemes Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes. BIRL module

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 199 Years

Sexes Eligible for Study:

All

Accepts 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:

Diagnosis of nAMD
Male and Female patients with ≥40 years of age at index
Decision to treatment with brolucizumab at baseline visit
Signed written informed consent
Patients for whom a therapy with brolucizumab is medically indicated
Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening

Exclusion Criteria:

Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
Patients treated for RVO, DME, mCNV, or 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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Luedenscheid	NRW	Germany	58507
2	Novartis Investigative Site	Trier	RP	Germany	54296
3	Novartis Investigative Site	Schneeberg	Sachsen	Germany	08289
4	Novartis Investigative Site	Aschersleben		Germany	06449
5	Novartis Investigative Site	Augsburg		Germany	86179
6	Novartis Investigative Site	Bayreuth		Germany	95445
7	Novartis Investigative Site	Berlin		Germany	10713
8	Novartis Investigative Site	Berlin		Germany	14163
9	Novartis Investigative Site	Bonn		Germany	53105
10	Novartis Investigative Site	Breisach am Rhein		Germany	79206
11	Novartis Investigative Site	Chemnitz		Germany	09113
12	Novartis Investigative Site	Dresden		Germany	01067
13	Novartis Investigative Site	Dresden		Germany	01257
14	Novartis Investigative Site	Dresden		Germany	01307
15	Novartis Investigative Site	Dresden		Germany	01324
16	Novartis Investigative Site	Duesseldorf		Germany	40212
17	Novartis Investigative Site	Esslingen		Germany	73728
18	Novartis Investigative Site	Frankfurt		Germany	60590
19	Novartis Investigative Site	Glauchau		Germany	08371
20	Novartis Investigative Site	Gottingen		Germany	37075
21	Novartis Investigative Site	Halle		Germany	06118
22	Novartis Investigative Site	Homburg		Germany	66421
23	Novartis Investigative Site	Hösbach		Germany	63768
24	Novartis Investigative Site	Kiel		Germany
25	Novartis Investigative Site	Koeln		Germany	50924
26	Novartis Investigative Site	Koeln		Germany	50968
27	Novartis Investigative Site	Leipzig		Germany	04103
28	Novartis Investigative Site	Leipzig		Germany	04106
29	Novartis Investigative Site	Magdeburg		Germany
30	Novartis Investigative Site	Marienberg		Germany	09496
31	Novartis Investigative Site	Muenchen		Germany	81377
32	Novartis Investigative Site	Muenster		Germany	48145
33	Novartis Investigative Site	Mutterstadt		Germany	67112
34	Novartis Investigative Site	Neubrandenburg		Germany	17036
35	Novartis Investigative Site	Neuburg		Germany	86633
36	Novartis Investigative Site	Osnabrück		Germany	49076
37	Novartis Investigative Site	Regensburg		Germany	93 047
38	Novartis Investigative Site	Rhauderfehn		Germany	26817
39	Novartis Investigative Site	Rostock		Germany	18057
40	Novartis Investigative Site	Saarbruecken		Germany
41	Novartis Investigative Site	Schoenebeck		Germany	39218
42	Novartis Investigative Site	Stralsund		Germany	18435
43	Novartis Investigative Site	Sulzbach		Germany	66280
44	Novartis Investigative Site	Torgau		Germany	04860
45	Novartis Investigative Site	Waren		Germany	17192
46	Novartis Investigative Site	Wuerzburg		Germany	97080
47	Novartis Investigative Site	Wuerzburg		Germany