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Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Brolucizumab 6mg
Aflibercept 2 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye
  • Total area of CNV>50% of the total lesion area in the study eye at screening

Exclusion Criteria:

  • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at Baseline.
  • Central subfield of the study eye affected by fibrosis or geographic atrophy
  • Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 mmHg
  • Previous treatment with any anti-VEGF drugs in the study eye.
  • Previous treatment with any approved or investigational drugs for neovascular AMD in the study eye.

Other protocol-specified inclusion or exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brolucizumab 6 mg

Aflibercept 2 mg

Arm Description

Outcomes

Primary Outcome Measures

Change in Best-Corrected Visual Acuity
To demonstrate that brolucizumab 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA
Average change in Best-Corrected Visual Acuity
To demonstrate that brolucizumab 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA

Secondary Outcome Measures

Proportion of subjects with treatment regimen of every 12 weeks in brolucizumab arm
To estimate the proportion of q12w subjects (1 injection every 12 weeks) up to Week 48 in the brolucizumab 6 mg treatment arm"
Proportion of patients with treatment regimen of every 12 weeks (q12w) interval at Week 48 of those who do not need every 8 weeks treatment interval in brolucizumab arm
To estimate the predictive value of the first regimen of every 12 weeks (q12w) cycle (at Week 16 and Week 20) for maintenance of q12w treatment regimen
Change in Best Corrected Visual Acuity (BCVA)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Average change in Best-Corrected Visual Acuity
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Average change in Best-Corrected Visual Acuity
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Proportion of patients who gain in best-correct visual acuity of 15/10/5 letters or more
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Percentage of subjects with Best-Corrected Visual Acuity of 73 letters or more at each visit
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Proportion of subjects who loss in best-corrected visual acuity of 15/10/5 letters or more
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Change in Central Subfield Thickness Total
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Average change in Central Subfield Thickness Total
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Average Change in Central Subfield Thickness Total
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Change in Central Subfield Thickness-neurosensory retina
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Change in in area of choroidal neovascularization lesion
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Proportion of subjects who have presence of subretinal and/or intraretinal fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Number of visits with simultaneous absence of subretinal and intraretinal fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Proportion of subjects who have presence of subretinal fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Proportion of subjects who have presence of intraretinal fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Proportion of subjects who presence of sub retinal pigment epithelium fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Change in Central Subfield Thickness Total
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Proportion of subjects who presence of subretinal and /or intraretinal fluid (central subfield)
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Proportion of subjects who need every 8 weeks injection
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Change in subject reported outcomes (Visual Function Questionnaire-25) total and subscale scores
To assess visual function-related subject reported outcomes following treatment with brolucizumab 6 mg relative to aflibercept 2 mg. The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question.
Proportion of subjects who have positive anti-drug antibodies status
To assess immunogenicity of brolucizumab 6 mg
Pharmacokinetic parameters: Cmax after first brolucizumab 6 mg dose in a subset of subjects
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Cmax (maximum concentration) of brolucizumab at 6 mg following a single intravitreal injection
Pharmacokinetic parameters: Tmax after first brolucizumab 6 mg dose in a subset of subjects
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Tmax (time to maximum concenration) of brolucizumab at 6 mg following a single intravitreal injection
Pharmacokinetic parameters: AUClast after first brolucizumab 6 mg dose in a subset of subjects
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess AUClast (Area under the curve up to the last validated measurable plasma concentration) of brolucizumab at 6 mg following a single intravitreal injection
Pharmacokinetic parameters: AUCinf after first brolucizumab 6 mg dose in a subset of subjects
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess AUCinf (area under the curve total exposure) of brolucizumab at 6 mg following a single intravitreal injection
Pharmacokinetic parameters: Thalf after first brolucizumab 6 mg dose in a subset of subjects
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Thalf (time to elimination of half-life) of brolucizumab at 6 mg following a single intravitreal injection

Full Information

First Posted
July 1, 2019
Last Updated
June 22, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04047472
Brief Title
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
Official Title
A Twelve-Month, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Comparing the Efficacy and Safety of Brolucizumab 6 mg Versus Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
March 5, 2024 (Anticipated)
Study Completion Date
March 5, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
494 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brolucizumab 6 mg
Arm Type
Experimental
Arm Title
Aflibercept 2 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Brolucizumab 6mg
Intervention Description
Subjects will receive Brolucizumab 3 x q4w up to Week 8 followed by q12w / q8w up to Week 40 or Week 44, depending on disease activity status.
Intervention Type
Drug
Intervention Name(s)
Aflibercept 2 mg
Intervention Description
Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.
Primary Outcome Measure Information:
Title
Change in Best-Corrected Visual Acuity
Description
To demonstrate that brolucizumab 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA
Time Frame
Baseline to Week 48
Title
Average change in Best-Corrected Visual Acuity
Description
To demonstrate that brolucizumab 6 mg is not inferior to aflibercept 2 mg with respect to the change in BCVA
Time Frame
Baseline, over the period Week 36 to Week 48
Secondary Outcome Measure Information:
Title
Proportion of subjects with treatment regimen of every 12 weeks in brolucizumab arm
Description
To estimate the proportion of q12w subjects (1 injection every 12 weeks) up to Week 48 in the brolucizumab 6 mg treatment arm"
Time Frame
Baseline up to Week 48
Title
Proportion of patients with treatment regimen of every 12 weeks (q12w) interval at Week 48 of those who do not need every 8 weeks treatment interval in brolucizumab arm
Description
To estimate the predictive value of the first regimen of every 12 weeks (q12w) cycle (at Week 16 and Week 20) for maintenance of q12w treatment regimen
Time Frame
Week 16, Week 20 and Week 48
Title
Change in Best Corrected Visual Acuity (BCVA)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline up to Week 48
Title
Average change in Best-Corrected Visual Acuity
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline, over the period of Week 4 to Week 48
Title
Average change in Best-Corrected Visual Acuity
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline, over the period of Week 12 to Week 48
Title
Proportion of patients who gain in best-correct visual acuity of 15/10/5 letters or more
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline up to Week 48
Title
Percentage of subjects with Best-Corrected Visual Acuity of 73 letters or more at each visit
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline up to Week 48
Title
Proportion of subjects who loss in best-corrected visual acuity of 15/10/5 letters or more
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period
Time Frame
Baseline up to Week 48
Title
Change in Central Subfield Thickness Total
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline up to Week 48
Title
Average change in Central Subfield Thickness Total
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline, over the period of Week 36 to Week 48
Title
Average Change in Central Subfield Thickness Total
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline, over the period of Week 4 to Week 48
Title
Change in Central Subfield Thickness-neurosensory retina
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
From Baseline up to Week 48
Title
Change in in area of choroidal neovascularization lesion
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline, Weeks 12 and Week 48
Title
Proportion of subjects who have presence of subretinal and/or intraretinal fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline up to Week 48, specifically at Week 16 and Week 48
Title
Number of visits with simultaneous absence of subretinal and intraretinal fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Over the period of Week 36 to Week 48
Title
Proportion of subjects who have presence of subretinal fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline up to Week 48
Title
Proportion of subjects who have presence of intraretinal fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline up to Week 48
Title
Proportion of subjects who presence of sub retinal pigment epithelium fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters
Time Frame
Baseline up to Week 48
Title
Change in Central Subfield Thickness Total
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Time Frame
Baseline up to week 16
Title
Proportion of subjects who presence of subretinal and /or intraretinal fluid (central subfield)
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Time Frame
At Week 16
Title
Proportion of subjects who need every 8 weeks injection
Description
To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg over the time period by assessing changes in anatomical parameters To evaluate the efficacy of brolucizumab 6 mg relative to aflibercept 2 mg at the end of the matched treatment phase
Time Frame
At Week 16
Title
Change in subject reported outcomes (Visual Function Questionnaire-25) total and subscale scores
Description
To assess visual function-related subject reported outcomes following treatment with brolucizumab 6 mg relative to aflibercept 2 mg. The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question.
Time Frame
Baseline up to Weeks 24 and Week 48
Title
Proportion of subjects who have positive anti-drug antibodies status
Description
To assess immunogenicity of brolucizumab 6 mg
Time Frame
At Baseline (enrollment), Weeks 4, 12, 24, 36, and 48 (End of Study)
Title
Pharmacokinetic parameters: Cmax after first brolucizumab 6 mg dose in a subset of subjects
Description
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Cmax (maximum concentration) of brolucizumab at 6 mg following a single intravitreal injection
Time Frame
Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Title
Pharmacokinetic parameters: Tmax after first brolucizumab 6 mg dose in a subset of subjects
Description
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Tmax (time to maximum concenration) of brolucizumab at 6 mg following a single intravitreal injection
Time Frame
Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Title
Pharmacokinetic parameters: AUClast after first brolucizumab 6 mg dose in a subset of subjects
Description
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess AUClast (Area under the curve up to the last validated measurable plasma concentration) of brolucizumab at 6 mg following a single intravitreal injection
Time Frame
Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Title
Pharmacokinetic parameters: AUCinf after first brolucizumab 6 mg dose in a subset of subjects
Description
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess AUCinf (area under the curve total exposure) of brolucizumab at 6 mg following a single intravitreal injection
Time Frame
Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Title
Pharmacokinetic parameters: Thalf after first brolucizumab 6 mg dose in a subset of subjects
Description
PK draw 6 hours post-injection on Day 1, after first brolucizumab 6 mg dose in a subset of subjects to assess Thalf (time to elimination of half-life) of brolucizumab at 6 mg following a single intravitreal injection
Time Frame
Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye Total area of CNV>50% of the total lesion area in the study eye at screening Exclusion Criteria: Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at Baseline. Central subfield of the study eye affected by fibrosis or geographic atrophy Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 mmHg Previous treatment with any anti-VEGF drugs in the study eye. Previous treatment with any approved or investigational drugs for neovascular AMD in the study eye. Other protocol-specified inclusion or exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
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
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
410015
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nanjing City
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Yixing
State/Province
Jiangsu
ZIP/Postal Code
214299
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Changchun City
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Shenyang City
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030002
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
ZIP/Postal Code
210036
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Active, not recruiting

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 vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

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