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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04278417




Registration number
NCT04278417
Ethics application status
Date submitted
18/02/2020
Date registered
20/02/2020

Titles & IDs
Public title
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
Scientific title
A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
Secondary ID [1] 0 0
CRTH258D2301
Universal Trial Number (UTN)
Trial acronym
CONDOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proliferative Diabetic Retinopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Brolucizumab 6 mg
Treatment: Surgery - Panretinal photocoagulation laser

Experimental: Brolucizumab 6 mg - Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90

Active comparator: Panretinal photocoagulation laser Arm - Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed


Treatment: Other: Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90

Treatment: Surgery: Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54
Timepoint [1] 0 0
Baseline, Week 54
Secondary outcome [1] 0 0
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54
Timepoint [1] 0 0
Week 54
Secondary outcome [2] 0 0
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54
Timepoint [2] 0 0
Up to Week 54
Secondary outcome [3] 0 0
Area Under the Curve in Change From Baseline in BCVA up to Week 54
Timepoint [3] 0 0
From Baseline, up to Week 54
Secondary outcome [4] 0 0
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With =2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54
Timepoint [4] 0 0
Baseline, Week 54
Secondary outcome [5] 0 0
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With =2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 18 and Week 54
Timepoint [5] 0 0
Baseline, Week 18, and Week 54
Secondary outcome [6] 0 0
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With =3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54
Timepoint [6] 0 0
Baseline and Week 54
Secondary outcome [7] 0 0
Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With =3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 18 and Week 54
Timepoint [7] 0 0
Baseline, Week 18, and Week 54
Secondary outcome [8] 0 0
Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54
Timepoint [8] 0 0
Up to Week 54
Secondary outcome [9] 0 0
Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye
Timepoint [9] 0 0
AEs are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the Week 54 tests (or Day 413 for pts who missed the Week 54 visit but were ongoing.) The study is still ongoing.
Secondary outcome [10] 0 0
Non-ocular AEs (= 2% in Any Treatment Arm) by Preferred Term
Timepoint [10] 0 0
AEs are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the Week 54 tests (or Day 413 for pts who missed the Week 54 visit but were ongoing.) The study is still ongoing.

Eligibility
Key inclusion criteria
* Signed informed consent must be obtained prior to participation
* Able to complete adequate fundus photographs and retinal images
* Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
* DM treatment stable for at least 3 months
* PDR diagnosis with no previous PRP treatment in the study eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
* Presence of diabetic macular edema in the study eye
* Active infection or inflammation in the study eye
* Uncontrolled glaucoma (IOP greater than 25 mmHg)
* Intravitreal anti-VEGF treatment within 6 months
* Treatment with intraocular corticosteroids
* End stage renal disease requiring dialysis or kidney transplant
* Uncontrolled blood pressure
* Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2024
Sample size
Target
Accrual to date
Final
689
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Albury
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [4] 0 0
Novartis Investigative Site - Strathfield
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2135 - Strathfield
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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Illinois
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Indiana
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Kansas
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Maryland
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Mississippi
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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De Santa Fe
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Argentina
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Caba
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Canada
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Ontario
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Canada
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Quebec
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Chile
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RM
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China
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Beijing
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China
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Guangdong
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China
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Hubei
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China
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Jiangsu
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China
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Jilin
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China
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Liaoning
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China
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Shaanxi
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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China
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Shanghai
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India
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Gujarat
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India
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Tamil Nadu
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India
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Tamilnadu
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India
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Chandigarh
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India
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New Delhi
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Aichi
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Chiba
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Fukui
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Japan
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Fukuoka
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Fukushima
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Hokkaido
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Kagawa
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Mie
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Nagano
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Tochigi
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Tokyo
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Akita
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Japan
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Kobe-shi
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Seocho Gu
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Ciudad de Mexico
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Mexico
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Tijuana
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Philippines
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NCR
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Philippines
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Makati
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Philippines
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Pasig City
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Puerto Rico
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Arecibo
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Russian Federation
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Cheboksary
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Sterlitamak
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Russian Federation
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Ulyanovsk
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Taiwan
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Hualien
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Taiwan
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Kaohsiung
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Turkey
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Ankara
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Istanbul
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Turkey
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Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04278417