Back to resultsA Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KITE)
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brolucizumab
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, intravitreal injection, brolucizumab, aflibercept, double-masked
Eligibility Criteria
Inclusion Criteria:
- Written informed consent before any assessment
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
- Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion Criteria:
- Active proliferative diabetic retinopathy in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
Other protocol-specified inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
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- Novartis Investigative Site
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- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brolucizumab 6 mg
Aflibercept 2 mg
Arm Description
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Outcomes
Primary Outcome Measures
Change from baseline in best-corrected visual acuity (BCVA) at Week 52
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Secondary Outcome Measures
Average change from baseline in BCVA over the period Week 40 through Week 52
Assessed with ETDRS visual acuity testing charts
Proportion of patients maintained at q12w up to Weeks 52 and 100
Positive treatment status is defined as IVT injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arm only.
Proportion of patients maintained at q12w up to Week 52 within those patients that qualified for q12w at Week 36
This outcome measure is pre-specified for brolucizumab treatment arm only.
Change from baseline in BCVA at each visit up to Week 100
Assessed with ETDRS visual acuity testing charts
Average change from baseline in BCVA over the period Week 4 to Week 52/100
Assessed with ETDRS visual acuity testing charts
Average change from baseline in BCVA over the period Week 20 to Week 52/100 and Week 28 to Week 52/100
Assessed with ETDRS visual acuity testing charts
Gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit
Assessed with ETDRS visual acuity testing charts
Time to achieve gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline (or reaching a score of 84 or more)
Assessed with ETDRS visual acuity testing charts
Loss in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit
Assessed with ETDRS visual acuity testing charts
Absolute BCVA ≥73 ETDRS letters at each post-baseline visit
Assessed with ETDRS visual acuity testing charts
Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals)
Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals), within those patients that qualified for q12w at Week 36
This outcome measure is pre-specified for brolucizumab treatment arm only
Proportion of patients maintained at q12w/q16w up to Week 100, within those patients that qualified for q12w at Week 36
This outcome measure is pre-specified for brolucizumab treatment arm only
Proportion of patients with disease activity at Week 32 (eg ≥5 letters loss in BCVA compared to Week 28)
This outcome measure is pre-specified for brolucizumab treatment arm only
Proportion of patients maintained on q16w up to Week 100 within the patients on q12 at Week 68 and on q16w at Week 76
Proportion of patients re-assigned and maintained on q12w up to Week 100 within the patients on q8w at Week 68 and on q12w at Week 80
Proportion of patients with injections per planned dosing regimen (every 8, 12 or 16 weeks)
This outcome measure is pre-specified for brolucizumab treatment arm only
Change from baseline in central subfield thickness (CSFT) at each assessment visit
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Average change from baseline in CSFT over the period Week 40 through Week 52 / Week 88 through Week 100
Assessed by SD-OCT
Average change from baseline in CSFT over the period Week 4 to Week 52 / 96
Assessed by SD-OCT
Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit
Assessed by SD-OCT
Change from baseline in central subfield thickness-neurosensory (CSFTns) at each assessment visit
Assessed by SD-OCT
Average change from baseline in CSFTns over the period Week 40 through Week 52 / Week 88 through Week 100
Assessed by SD-OCT
Average change from baseline in CSFTns over the period Week 4 to Week 52 / 100
Proportion of patients with presence of subretinal fluid (SRF) at each assessment visit
Assessed by SD-OCT, angiography, and/or color fundus photography
Proportion of patients with presence of intraretinal fluid (IRF) at each assessment visit
Assessed by SD-OCT, angiography, and/or color fundus photography
Proportion of patients with simultaneous absence of SRF and IRF at each assessment visit
Assessed by SD-OCT, angiography, and/or color fundus photography
Proportion of patients with presence of leakage on fluorescein angiography (FA) at Weeks 52 and 100
Assessed by fluorescein angiography
Change from baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) score at each assessment visit
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative
Number of patients with progression to proliferative diabetic retinopathy (PDR) as assessed by ETDRS-DRSS Score of at least 61 by Week 52 and Week 100
ETDRS-DRSS
Change from baseline in patient reported outcomes (VFQ-25) total and subscale scores up to Week 100
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains
Systemic brolucizumab/aflibercept concentration
Blood draw
Anti-Drug Antibody (ADA) status
Blood draw
Average change from baseline in BCVA from the period Week 88 to 100
Assessed with ETDRS visual acuity testing charts
Full Information
NCT ID
NCT03481660
First Posted
March 19, 2018
Last Updated
February 10, 2022
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03481660
Brief Title
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Acronym
KITE
Official Title
A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
June 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Detailed Description
In this 2-year, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 1:1 ratio to one of the two treatment arms and attend 28 planned visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, intravitreal injection, brolucizumab, aflibercept, double-masked
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brolucizumab 6 mg
Arm Type
Experimental
Arm Description
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
Arm Title
Aflibercept 2 mg
Arm Type
Active Comparator
Arm Description
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Brolucizumab
Other Intervention Name(s)
RTH258, ESBA1008
Intervention Description
Intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal injection
Primary Outcome Measure Information:
Title
Change from baseline in best-corrected visual acuity (BCVA) at Week 52
Description
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Average change from baseline in BCVA over the period Week 40 through Week 52
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 52
Title
Proportion of patients maintained at q12w up to Weeks 52 and 100
Description
Positive treatment status is defined as IVT injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arm only.
Time Frame
Up to Week 100
Title
Proportion of patients maintained at q12w up to Week 52 within those patients that qualified for q12w at Week 36
Description
This outcome measure is pre-specified for brolucizumab treatment arm only.
Time Frame
Up to Week 52
Title
Change from baseline in BCVA at each visit up to Week 100
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Average change from baseline in BCVA over the period Week 4 to Week 52/100
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Average change from baseline in BCVA over the period Week 20 to Week 52/100 and Week 28 to Week 52/100
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Time to achieve gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline (or reaching a score of 84 or more)
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Loss in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Absolute BCVA ≥73 ETDRS letters at each post-baseline visit
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
Title
Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals)
Time Frame
Up to Week 64
Title
Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals), within those patients that qualified for q12w at Week 36
Description
This outcome measure is pre-specified for brolucizumab treatment arm only
Time Frame
Up to Week 64
Title
Proportion of patients maintained at q12w/q16w up to Week 100, within those patients that qualified for q12w at Week 36
Description
This outcome measure is pre-specified for brolucizumab treatment arm only
Time Frame
Up to Week 100
Title
Proportion of patients with disease activity at Week 32 (eg ≥5 letters loss in BCVA compared to Week 28)
Description
This outcome measure is pre-specified for brolucizumab treatment arm only
Time Frame
Week 28, Week 32
Title
Proportion of patients maintained on q16w up to Week 100 within the patients on q12 at Week 68 and on q16w at Week 76
Time Frame
Up to Week 100
Title
Proportion of patients re-assigned and maintained on q12w up to Week 100 within the patients on q8w at Week 68 and on q12w at Week 80
Time Frame
Up to Week 100
Title
Proportion of patients with injections per planned dosing regimen (every 8, 12 or 16 weeks)
Description
This outcome measure is pre-specified for brolucizumab treatment arm only
Time Frame
Up to Week 100
Title
Change from baseline in central subfield thickness (CSFT) at each assessment visit
Description
Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time Frame
Baseline up to Week 100
Title
Average change from baseline in CSFT over the period Week 40 through Week 52 / Week 88 through Week 100
Description
Assessed by SD-OCT
Time Frame
Baseline up to Week 100
Title
Average change from baseline in CSFT over the period Week 4 to Week 52 / 96
Description
Assessed by SD-OCT
Time Frame
Baseline up to Week 96
Title
Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit
Description
Assessed by SD-OCT
Time Frame
Baseline up to Week 100
Title
Change from baseline in central subfield thickness-neurosensory (CSFTns) at each assessment visit
Description
Assessed by SD-OCT
Time Frame
Baseline up to Week 100
Title
Average change from baseline in CSFTns over the period Week 40 through Week 52 / Week 88 through Week 100
Description
Assessed by SD-OCT
Time Frame
Baseline up to Week 100
Title
Average change from baseline in CSFTns over the period Week 4 to Week 52 / 100
Time Frame
Baseline up to Week 100
Title
Proportion of patients with presence of subretinal fluid (SRF) at each assessment visit
Description
Assessed by SD-OCT, angiography, and/or color fundus photography
Time Frame
Baseline up to Week 100
Title
Proportion of patients with presence of intraretinal fluid (IRF) at each assessment visit
Description
Assessed by SD-OCT, angiography, and/or color fundus photography
Time Frame
Baseline up to Week 100
Title
Proportion of patients with simultaneous absence of SRF and IRF at each assessment visit
Description
Assessed by SD-OCT, angiography, and/or color fundus photography
Time Frame
Baseline up to Week 100
Title
Proportion of patients with presence of leakage on fluorescein angiography (FA) at Weeks 52 and 100
Description
Assessed by fluorescein angiography
Time Frame
Up to Week 100
Title
Change from baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) score at each assessment visit
Description
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative
Time Frame
Baseline up to Week 100
Title
Number of patients with progression to proliferative diabetic retinopathy (PDR) as assessed by ETDRS-DRSS Score of at least 61 by Week 52 and Week 100
Description
ETDRS-DRSS
Time Frame
Baseline up to Week 100
Title
Change from baseline in patient reported outcomes (VFQ-25) total and subscale scores up to Week 100
Description
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains
Time Frame
Baseline up to Week 100
Title
Systemic brolucizumab/aflibercept concentration
Description
Blood draw
Time Frame
Up to Week 24
Title
Anti-Drug Antibody (ADA) status
Description
Blood draw
Time Frame
Up to Week 100
Title
Average change from baseline in BCVA from the period Week 88 to 100
Description
Assessed with ETDRS visual acuity testing charts
Time Frame
Baseline up to Week 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent before any assessment
Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion Criteria:
Active proliferative diabetic retinopathy in the study eye
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
Stroke or myocardial infarction during the 6-month period prior to baseline
Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
Other protocol-specified inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Hradec Kralove
State/Province
CZE
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Novartis Investigative Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
11412
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Bobigny cedex
State/Province
Seine Saint Denis
ZIP/Postal Code
93009
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69275
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
F 13008
Country
France
Facility Name
Novartis Investigative Site
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Novartis Investigative Site
City
Nyiregyhaza
ZIP/Postal Code
H 4400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
H 6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Novartis Investigative Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Telangana
Country
India
Facility Name
Novartis Investigative Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602739
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
116-5311
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
70-933
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
LT 50161
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT 08661
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80 809
Country
Poland
Facility Name
Novartis Investigative Site
City
Cheboksary
ZIP/Postal Code
428028
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420066
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
S308433
Country
Singapore
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
83301
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Poprad
ZIP/Postal Code
058 45
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Oerebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zuerich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com.
Learn more about this trial
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
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