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Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (CONDOR)

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brolucizumab 6 mg
Panretinal photocoagulation laser
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation
  2. Able to complete adequate fundus photographs and retinal images
  3. Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
  4. DM treatment stable for at least 3 months
  5. PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria:

  1. Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  2. Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye
  3. Uncontrolled glaucoma (IOP greater than 25 mmHg)
  4. Intravitreal anti-VEGF treatment within 6 months
  5. Treatment with intraocular corticosteroids
  6. End stage renal disease requiring dialysis or kidney transplant
  7. Uncontrolled blood pressure
  8. Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brolucizumab Arm

Panretinal photocoagulation laser Arm

Arm Description

Intra-vitreal injection

laser

Outcomes

Primary Outcome Measures

Change from Baseline in BCVA
To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54

Secondary Outcome Measures

Proportion of subjects with no PDR at Week 54
To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54
Proportion of subjects with center-involved DME up to Week 54
To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54
Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96
To compare the effect of brolucizumab relative to PRP with respect to visual acuity
Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96
To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
Proportion of subjects with no PDR at Week 96
To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96
To compare the effect of brolucizumab relative to PRP on ocular complications
Proportion of subjects with center-involved DME up to Week 96
To compare the effect of brolucizumab relative to PRP on ocular complications

Full Information

First Posted
February 18, 2020
Last Updated
July 7, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04278417
Brief Title
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
Acronym
CONDOR
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
694 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brolucizumab Arm
Arm Type
Experimental
Arm Description
Intra-vitreal injection
Arm Title
Panretinal photocoagulation laser Arm
Arm Type
Active Comparator
Arm Description
laser
Intervention Type
Biological
Intervention Name(s)
Brolucizumab 6 mg
Other Intervention Name(s)
RTH258
Intervention Description
3 x q6w loading injections, followed by q12w maintenance through Week 90
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation laser
Other Intervention Name(s)
PRP
Intervention Description
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Primary Outcome Measure Information:
Title
Change from Baseline in BCVA
Description
To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54
Time Frame
At Week 54
Secondary Outcome Measure Information:
Title
Proportion of subjects with no PDR at Week 54
Description
To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54
Time Frame
At Week 54
Title
Proportion of subjects with center-involved DME up to Week 54
Description
To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54
Time Frame
At Week 54
Title
Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96
Description
To compare the effect of brolucizumab relative to PRP with respect to visual acuity
Time Frame
From Baseline in BCVA up to Week 54 and Week 96
Title
Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96
Description
To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
Time Frame
From Baseline score to Week 54 and Week 96
Title
Proportion of subjects with no PDR at Week 96
Description
To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
Time Frame
At Week 96
Title
Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96
Description
To compare the effect of brolucizumab relative to PRP on ocular complications
Time Frame
At Week 54 and Week 96
Title
Proportion of subjects with center-involved DME up to Week 96
Description
To compare the effect of brolucizumab relative to PRP on ocular complications
Time Frame
At Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Novartis Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novartis Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Novartis Investigative Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509-2910
Country
United States
Facility Name
Novartis Investigative Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novartis Investigative Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Novartis Investigative Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912-7125
Country
United States
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novartis Investigative Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33801
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Novartis Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Novartis Investigative Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
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United States
Facility Name
Novartis Investigative Site
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
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United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
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United States
Facility Name
Novartis Investigative Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
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United States
Facility Name
Novartis Investigative Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Novartis Investigative Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
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United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
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United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Novartis Investigative Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Novartis Investigative Site
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novartis Investigative Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Novartis Investigative Site
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Novartis Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1116
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
De Santa Fe
ZIP/Postal Code
B7602
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
Country
Argentina
Facility Name
Novartis Investigative Site
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Novartis Investigative Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Novartis Investigative Site
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Novartis Investigative Site
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Novartis Investigative Site
City
Blumenau
State/Province
SC
ZIP/Postal Code
89052-504
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01427-002
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01525-001
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18031-060
Country
Brazil
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Novartis Investigative Site
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
RM
ZIP/Postal Code
7560994
Country
Chile
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Novartis Investigative Site
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing City
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Novartis Investigative Site
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Novartis Investigative Site
City
Changchun City
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Novartis Investigative Site
City
Shenyang City
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Novartis Investigative Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Novartis Investigative Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Novartis Investigative Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
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
Tirunelveli
State/Province
Tamilnadu
ZIP/Postal Code
627003
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
110 029
Country
India
Facility Name
Novartis Investigative Site
City
Nagakute-city
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466 8560
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Novartis Investigative Site
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurume city
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Novartis Investigative Site
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Novartis Investigative Site
City
Asahikawa-city
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Novartis Investigative Site
City
Tsu-city
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsumoto-city
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Novartis Investigative Site
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Novartis Investigative Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji-city
State/Province
Tokyo
ZIP/Postal Code
193-0944
Country
Japan
Facility Name
Novartis Investigative Site
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Novartis Investigative Site
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
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
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705703
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
Ciudad De Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06800
Country
Mexico
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Novartis Investigative Site
City
Tijuana
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Novartis Investigative Site
City
Makati
State/Province
NCR
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Novartis Investigative Site
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Novartis Investigative Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Novartis Investigative Site
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
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
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Sterlitamak
ZIP/Postal Code
453128
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34420
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
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 www.clinicalstudydatarequest.com

Learn more about this trial

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

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