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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
Date last updated
25/03/2025

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
Assessment method [1] 0 0
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.
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
Assessment method [1] 0 0
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.
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
Assessment method [2] 0 0
Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser
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
Assessment method [3] 0 0
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.
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
Assessment method [4] 0 0
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.
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
Assessment method [5] 0 0
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.
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
Assessment method [6] 0 0
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.
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
Assessment method [7] 0 0
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.
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
Assessment method [8] 0 0
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
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
Assessment method [9] 0 0
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
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
Assessment method [10] 0 0
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
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
De Santa Fe
Country [19] 0 0
Argentina
State/province [19] 0 0
Caba
Country [20] 0 0
Brazil
State/province [20] 0 0
RS
Country [21] 0 0
Brazil
State/province [21] 0 0
SC
Country [22] 0 0
Brazil
State/province [22] 0 0
SP
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Chile
State/province [25] 0 0
RM
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Guangdong
Country [28] 0 0
China
State/province [28] 0 0
Hubei
Country [29] 0 0
China
State/province [29] 0 0
Jiangsu
Country [30] 0 0
China
State/province [30] 0 0
Jilin
Country [31] 0 0
China
State/province [31] 0 0
Liaoning
Country [32] 0 0
China
State/province [32] 0 0
Shaanxi
Country [33] 0 0
China
State/province [33] 0 0
Sichuan
Country [34] 0 0
China
State/province [34] 0 0
Tianjin
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
China
State/province [36] 0 0
Shanghai
Country [37] 0 0
India
State/province [37] 0 0
Gujarat
Country [38] 0 0
India
State/province [38] 0 0
Tamil Nadu
Country [39] 0 0
India
State/province [39] 0 0
Tamilnadu
Country [40] 0 0
India
State/province [40] 0 0
Chandigarh
Country [41] 0 0
India
State/province [41] 0 0
New Delhi
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi
Country [43] 0 0
Japan
State/province [43] 0 0
Chiba
Country [44] 0 0
Japan
State/province [44] 0 0
Fukui
Country [45] 0 0
Japan
State/province [45] 0 0
Fukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Fukushima
Country [47] 0 0
Japan
State/province [47] 0 0
Hokkaido
Country [48] 0 0
Japan
State/province [48] 0 0
Kagawa
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Japan
State/province [49] 0 0
Mie
Country [50] 0 0
Japan
State/province [50] 0 0
Nagano
Country [51] 0 0
Japan
State/province [51] 0 0
Tochigi
Country [52] 0 0
Japan
State/province [52] 0 0
Tokyo
Country [53] 0 0
Japan
State/province [53] 0 0
Akita
Country [54] 0 0
Japan
State/province [54] 0 0
Kobe-shi
Country [55] 0 0
Japan
State/province [55] 0 0
Osaka
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Gyeonggi Do
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seocho Gu
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Daegu
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Mexico
State/province [60] 0 0
Distrito Federal
Country [61] 0 0
Mexico
State/province [61] 0 0
Ciudad de Mexico
Country [62] 0 0
Mexico
State/province [62] 0 0
Tijuana
Country [63] 0 0
Philippines
State/province [63] 0 0
NCR
Country [64] 0 0
Philippines
State/province [64] 0 0
Makati
Country [65] 0 0
Philippines
State/province [65] 0 0
Pasig City
Country [66] 0 0
Puerto Rico
State/province [66] 0 0
Arecibo
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Cheboksary
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ekaterinburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Omsk
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Sterlitamak
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Ulyanovsk
Country [73] 0 0
Taiwan
State/province [73] 0 0
Hualien
Country [74] 0 0
Taiwan
State/province [74] 0 0
Kaohsiung
Country [75] 0 0
Turkey
State/province [75] 0 0
Ankara
Country [76] 0 0
Turkey
State/province [76] 0 0
Istanbul
Country [77] 0 0
Turkey
State/province [77] 0 0
Izmir

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


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