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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
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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
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Secondary ID [1]
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CRTH258D2301
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Universal Trial Number (UTN)
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Trial acronym
CONDOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Proliferative Diabetic Retinopathy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54
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Assessment method [1]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included.
Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
Last observation carried forward (LOCF) was used for the imputation of missing values.
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Timepoint [1]
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Baseline, Week 54
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Secondary outcome [1]
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Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54
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Assessment method [1]
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Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) \< 7.
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Timepoint [1]
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Week 54
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Secondary outcome [2]
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Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54
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Assessment method [2]
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Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
PRP = Panretinal photocoagulation laser
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Timepoint [2]
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Up to Week 54
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Secondary outcome [3]
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Area Under the Curve in Change From Baseline in BCVA up to Week 54
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Assessment method [3]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included.
Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
Last observation carried forward (LOCF) was used for the imputation of missing values.
The AUC in change from Baseline in BCVA up to Week 54 is referred to as the averaged change from Baseline in BCVA at each visit up to Week 54, which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54) / number of visits with valid BCVA data from Week 6 to Week 54 - BCVA at Baseline.
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Timepoint [3]
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From Baseline, up to Week 54
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Secondary outcome [4]
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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
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Assessment method [4]
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The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative.
Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the =2-step and =3-step change from baseline for each post-baseline assessment".
A lower score represents better functioning.
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Timepoint [4]
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Baseline, Week 54
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Secondary outcome [5]
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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
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Assessment method [5]
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The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative.
Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the =2-step and =3-step change from baseline for each post-baseline assessment".
A lower score represents better functioning.
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Timepoint [5]
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Baseline, Week 18, and Week 54
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Secondary outcome [6]
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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
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Assessment method [6]
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The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative.
Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the =2-step and =3-step change from baseline for each post-baseline assessment".
A lower score represents better functioning.
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Timepoint [6]
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Baseline and Week 54
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Secondary outcome [7]
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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
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Assessment method [7]
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The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative.
Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the =2-step and =3-step change from baseline for each post-baseline assessment".
A lower score represents better functioning.
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Timepoint [7]
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Baseline, Week 18, and Week 54
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Secondary outcome [8]
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Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54
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Assessment method [8]
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The vision-threatening complications associated with Diabetic retinopathy (DR) are defined as any event of the following list occurring in the study eye at any time point after Baseline:
* Center-involved Diabetic macular edema (CI-DME) as defined as Central sub-field thickness (CSFT) =280 µm according to Central reading center (CRC) evaluation of Optical coherent tomography (OCT) image
* Retinal detachment
* Vitreous hemorrhage
* Neovascular glaucoma, iris/ anterior chamber angle neovascularization
* Vitrectomy for DR complications
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Timepoint [8]
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Up to Week 54
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Secondary outcome [9]
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Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye
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Assessment method [9]
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An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
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Timepoint [9]
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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.
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Secondary outcome [10]
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Non-ocular AEs (= 2% in Any Treatment Arm) by Preferred Term
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Assessment method [10]
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An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
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Timepoint [10]
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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.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
689
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Albury
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Novartis Investigative Site - Liverpool
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Novartis Investigative Site - Parramatta
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Novartis Investigative Site - Strathfield
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2640 - Albury
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Recruitment postcode(s) [2]
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2170 - Liverpool
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2150 - Parramatta
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Recruitment postcode(s) [4]
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2135 - Strathfield
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Recruitment outside Australia
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.
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Trial website
https://clinicaltrials.gov/study/NCT04278417
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/17/NCT04278417/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/17/NCT04278417/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04278417