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Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

Primary Purpose

Branch Retinal Vein Occlusion

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Brolucizumab 6 mg

Aflibercept 2 mg

Sham injection

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Visual impairment, Macular edema, Branch retinal vein occlusion, BRVO, Brolucizumab, Aflibercept, Vascular endothelial growth factor, VEGF, anti-VEGF

Eligibility Criteria

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

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening.
BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion criteria

Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded.
Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline
Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline
Previous use of intraocular or periocular steroids in study eye at any time prior to baseline
Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline
Intraocular surgery in the study eye during the 3-month period prior to baseline
Vitreoretinal surgery in the study eye at any time prior to baseline
Aphakia with the absence of posterior capsule in the study eye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brolucizumab 6 mg

Aflibercept 2 mg

Arm Description

1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)

Outcomes

Primary Outcome Measures

Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.

Secondary Outcome Measures

Change From Baseline in BCVA Averaged Over Week 40 to Week 52

An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Change From Baseline in BCVA Averaged Over Week 64 to Week 76

An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Change From Baseline in BCVA by Visit up to Week 76

Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline

The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.

Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline

The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.

Change From Baseline in CSFT Averaged Over Week 40 to Week 52

Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Change From Baseline in CSFT Averaged Over Week 64 to Week 76

Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Change From Baseline in CSFT by Visit up to Week 76

Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76

Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76

Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72

Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented

Time to Recurrence After Week 20 and up to Week 76

Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76. For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).

Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76

Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).

Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL). The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.

Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76

Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.

Full Information

NCT ID

NCT03802630

First Posted

January 10, 2019

Last Updated

January 27, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03802630

Brief Title

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

Acronym

RAPTOR

Official Title

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated by sponsor due to increased incidences of AEs of special interest (intraocular inflammation including retinal vasculitis and retinal vascular occlusion), in patients dosed brolucizumab 6mg every 4 weeks beyond 3 initial doses

Study Start Date

July 2, 2019 (Actual)

Primary Completion Date

July 26, 2021 (Actual)

Study Completion Date

July 26, 2021 (Actual)

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

Detailed Description

The study was comprised of a Screening period (Day -28 to Day -1), Double-masked treatment period (Day 1 to Week 72) and Post-treatment follow-up period (Week 72 to Week 76). Treatment visits were scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects entered a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability was performed at each monthly visit and subjects received either an active or a sham injection. Treatment with active was interrupted when disease stability was reached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Branch Retinal Vein Occlusion

Keywords

Visual impairment, Macular edema, Branch retinal vein occlusion, BRVO, Brolucizumab, Aflibercept, Vascular endothelial growth factor, VEGF, anti-VEGF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

A masked evaluating investigator was responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator performed the injections and assessed patient safety following the injections.

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brolucizumab 6 mg

Arm Type

Experimental

Arm Description

1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)

Arm Title

Aflibercept 2 mg

Arm Type

Active Comparator

Arm Description

1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)

Intervention Type

Drug

Intervention Name(s)

Brolucizumab 6 mg

Other Intervention Name(s)

RTH258, ESBA1008

Intervention Description

Solution for injection (intravitreal use)

Intervention Type

Drug

Intervention Name(s)

Aflibercept 2 mg

Other Intervention Name(s)

EYLEA®

Intervention Description

Solution for injection (Intravitreal use)

Intervention Type

Other

Intervention Name(s)

Sham injection

Intervention Description

Empty sterile syringe without a needle administered as a sham injection for masking purposes. From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.

Primary Outcome Measure Information:

Title

Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in BCVA Averaged Over Week 40 to Week 52

Description

Time Frame

Baseline, Week 40 to Week 52

Title

Change From Baseline in BCVA Averaged Over Week 64 to Week 76

Description

Time Frame

Baseline, Week 64 to Week 76

Title

Change From Baseline in BCVA by Visit up to Week 76

Description

Time Frame

Baseline and every 4 weeks from baseline up to Week 76

Title

Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline

Description

Time Frame

Baseline and every 4 weeks from baseline up to Week 76

Title

Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline

Description

Time Frame

Baseline and every 4 weeks from baseline up to Week 76

Title

Change From Baseline in CSFT Averaged Over Week 40 to Week 52

Description

Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Time Frame

Baseline, Week 40 to Week 52

Title

Change From Baseline in CSFT Averaged Over Week 64 to Week 76

Description

Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Time Frame

Baseline, Week 64 to Week 76

Title

Change From Baseline in CSFT by Visit up to Week 76

Description

Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Time Frame

Baseline, and every 4 weeks from baseline up to Week 76

Title

Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76

Description

Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

Time Frame

Every 4 weeks from baseline up to Week 76

Title

Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76

Description

Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Time Frame

Every 4 weeks from Week 4 up to Week 76

Title

Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72

Description

Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented

Time Frame

Week 24 to Week 52 and Week 24 to Week 72

Title

Time to Recurrence After Week 20 and up to Week 76

Description

Time Frame

Week 20 to Week 76

Title

Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76

Description

Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).

Time Frame

Baseline to Week 76

Title

Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76

Description

Time Frame

Baseline, Week 24, Week 52 and Week 76

Title

Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76

Description

Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.

Time Frame

Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening. BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits. Exclusion criteria Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded. Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract) Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline Previous use of intraocular or periocular steroids in study eye at any time prior to baseline Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline Intraocular surgery in the study eye during the 3-month period prior to baseline Vitreoretinal surgery in the study eye at any time prior to baseline Aphakia with the absence of posterior capsule in the study eye

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

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Novartis Investigative Site

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93103

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33711

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46280

Country

United States

Facility Name

Novartis Investigative Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Novartis Investigative Site

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

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

Stoneham

State/Province

Massachusetts

ZIP/Postal Code

02180

Country

United States

Facility Name

Novartis Investigative Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Novartis Investigative Site

City

Bloomfield

State/Province

New Jersey

ZIP/Postal Code

07003

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

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

Monroeville

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Novartis Investigative Site

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

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

Austin

State/Province

Texas

ZIP/Postal Code

78750

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

Houston

State/Province

Texas

ZIP/Postal Code

77025

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

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705-3611

Country

United States

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2H0C8

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Z 8R2

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

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Novartis Investigative Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

Facility Name

Novartis Investigative Site

City

Wuxi

State/Province

Jiangsu

ZIP/Postal Code

214002

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

100044

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Strasbourg

State/Province

Bas Rhin

ZIP/Postal Code

67000

Country

France

Facility Name

Novartis Investigative Site

City

Saint Cyr sur Loire

State/Province

Indre Et Loire

ZIP/Postal Code

37540

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Novartis Investigative Site

City

Creteil

ZIP/Postal Code

94000

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

F 13008

Country

France

Facility Name

Novartis Investigative Site

City

Paris cedex 10

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hongkong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Novartis Investigative Site

City

Zerifin

ZIP/Postal Code

6093000

Country

Israel

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00198

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Novartis Investigative Site

City

Amagasaki city

State/Province

Hyogo

ZIP/Postal Code

660 8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Ishioka

State/Province

Ibaraki

ZIP/Postal Code

315-0037

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

Taito-ku

State/Province

Tokyo

ZIP/Postal Code

111-0051

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

543-0027

Country

Japan

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

Moscow

ZIP/Postal Code

119021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sterlitamak

ZIP/Postal Code

453128

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85107

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

ZIP/Postal Code

950 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Cugat

State/Province

Catalunya

ZIP/Postal Code

08190

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08021

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1006

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Binningen

ZIP/Postal Code

4102

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Westcliff-on-Sea

State/Province

Essex

ZIP/Postal Code

SS0 0RY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

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

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17957

Description

Results for CRTH258C2301 from the Novartis Clinical Trials Website

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1191

Description

A Plain Language Trial Summary is available on novctrd.com

Learn more about this trial

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

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Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (RAPTOR)

Branch Retinal Vein Occlusion

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial