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Trial details
Trial details
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Current status:
Approved
|
Date registered:
06/03/2019
Trial version(s)
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
Current: 20/02/2019
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Main Information
Primary registry identifying number
LBCTR2019030200
Protocol number
RTH258B2302
MOH registration number
31193/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
23/07/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Acronym
KITE
Scientific 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
Acronym
Brief summary of the study: English
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).
Brief summary of the study: Arabic
دراسة مرحلة ثالثة، متعدّدة المراكز، مزدوجة التعمية، عشوائيّة التوزيع، من مجموعتين، مدّتها سنتان، لتقييم فعاليّة وسلامة دواء برولوسيزوماب مقابل دواء أفليبرسبت لدى المرضى البالغين المصابين بضعف بصريّ ناتج عن الوذمة البقعيّة السكّريّة
Health conditions/problem studied: Specify
Patients With Visual Impairment Due to Diabetic Macular Edema
Interventions: Specify
•Drug: Brolucizumab Intravitreal injection Other Name: RTH258, ESBA1008 •Drug: Aflibercept Intravitreal injection Other Name: Eylea
Key inclusion and exclusion 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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
90
Key inclusion and exclusion criteria: 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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Therapy and Safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
RTH258 (Brolucizumab)
Type of IMP
Immunological
Pharmaceutical class
Anti VEGF-A
Therapeutic indication
Diabetic Macular Edema
Therapeutic benefit
Change from baseline in best-corrected visual acuity (BCVA) at Week 52
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples will be exported to : Q2 solutions The Alba campus Rosebank Livingston EH547EG United Kingdom Phone : 44 (0) 2033 184 884 x2401 Biosamples include Urine and Blood Urine for general analysis Blood : CBC, Chemistry, HbA1c, Lipids Panel, Anti Drug Ab, Pharmacogenomics
Target sample size
10
Actual enrollment target size
1
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/03/2019
Date of study closure: Type
Actual
Date of study closure: Date
22/12/2021
Recruitment status
Recruiting
Date of completion
24/06/2019
IPD sharing statement plan
No
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03481660?term=CRTH258B2302&rank=1&view=record
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical Trials. gov
NCT03481660
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Naji
Waked
Beirut
Lebanon
009613252552
wakednaji@yahoo.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Georges
Azar
Dbayeh
Lebanon
009613550891
georgesazar@hotmail.com
Eye and Ear Hospital International
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr. Naji Waked
Ophthalmology
Approved
Eye and Ear Hospital International
Dr. Georges Azar
Ophthalmology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
30/04/2018
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Other
Hotel Dieu De France ( Eye and Ear Hospital International)
02/10/2018
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Lebanon
Belgium
Bulgaria
Czech Republic
Denmark
Estonia
France
Germany
Hungary
India
Republic of Korea
Latvia
Lithuania
Malaysia
Norway
Singapore
Slovakia
Sweden
Switzerland
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Diabetic macular edema
Oedema, unspecified (R60.9)
Macular Edema
Interventions
Intervention
Description
Keyword
Physical Exam, Vital signs, ophtalmic Exam, IOP, Optical Coherence Tomography, Fluorescein Angiography, Color Fundus photography, Urinalysis, Serum/ urine pregnancy test, lab test, completion of QoL questionnaires
ICF, Lab, questionnaires, Medication administration, physical examination
ICF, Lab tests, Questionnaires, Medication administration
Primary Outcomes
Name
Time points
Measure
Change from baseline in best-corrected visual acuity (BCVA)
Baseline, week 52
baseline, week 52
Key Secondary Outcomes
Name
Time points
Measure
Average change from baseline in BCVA
wk 40 till wk 52
wk 40 till wk 52
Proportion of patients with injections per planned dosing regimen
wk8,12,16
wk8,12,16
Change from baseline in central subfield thickness
baseline up to wk 100
baseline up to wk 100
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial