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

NCT ID: NCT03810313

Last Updated: 2023-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2021-07-26

Brief Summary

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

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Detailed Description

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The study included 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.

Conditions

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Central Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Brolucizumab 6 mg

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

Group Type EXPERIMENTAL

Brolucizumab 6 mg

Intervention Type DRUG

Solution for injection (intravitreal use)

Sham injection

Intervention Type OTHER

Empty sterile syringe without a needle administered as a sham injection for masking. 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.

Aflibercept 2 mg

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

Group Type ACTIVE_COMPARATOR

Aflibercept 2 mg

Intervention Type DRUG

Solution for injection (Intravitreal use)

Sham injection

Intervention Type OTHER

Empty sterile syringe without a needle administered as a sham injection for masking. 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.

Interventions

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Brolucizumab 6 mg

Solution for injection (intravitreal use)

Intervention Type DRUG

Aflibercept 2 mg

Solution for injection (Intravitreal use)

Intervention Type DRUG

Sham injection

Empty sterile syringe without a needle administered as a sham injection for masking. 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.

Intervention Type OTHER

Other Intervention Names

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RTH258 ESBA1008 EYLEA®

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent must be obtained prior to participation in the study.
* Patients with visual impairment due to ME secondary to CRVO 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 CRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema).
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Phoenix, Arizona, United States

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La Jolla, California, United States

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Mountain View, California, United States

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Santa Barbara, California, United States

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Colorado Springs, Colorado, United States

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Fort Myers, Florida, United States

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St. Petersburg, Florida, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Leawood, Kansas, United States

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Lenexa, Kansas, United States

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Stoneham, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Reno, Nevada, United States

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Bloomfield, New Jersey, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Monroeville, Pennsylvania, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Madison, Wisconsin, United States

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Albury, New South Wales, Australia

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Parramatta, New South Wales, Australia

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Strathfield, New South Wales, Australia

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Sydney, New South Wales, Australia

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Hobart, Tasmania, Australia

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Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Calgary, Alberta, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Québec, , Canada

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Guangzhou, Guangdong, China

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Shantou, Guangdong, China

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Harbin, Heilongjiang, China

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Wuhan, Hubei, China

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Wuxi, Jiangsu, China

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Chengdu, Sichuan, China

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Tianjin, Tianjin Municipality, China

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Tianjin, Tianjin Municipality, China

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Wenzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Chongqing, , China

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Shanghai, , China

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Hradec Králové, CZE, Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Créteil, , France

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Dijon, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Regensburg, Bavaria, Germany

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Düsseldorf, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Münster, , Germany

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Ulm, , Germany

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Heraklion Crete, Greece, Greece

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Larissa, GR, Greece

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Pécs, Baranya, Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Szeged, , Hungary

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Bari, BA, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Nagakute, Aichi-ken, Japan

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Kōriyama, Fukushima, Japan

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Kita-gun, Kagawa-ken, Japan

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Tsu, Mie-ken, Japan

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Matsumoto, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Taito-ku, Tokyo, Japan

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Batu Caves, Selangor, Malaysia

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Shah Alam, Selangor, Malaysia

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Tilburg, , Netherlands

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Arecibo, , Puerto Rico

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Cheboksary, , Russia

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Kazan', , Russia

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Saint Petersburg, , Russia

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Yekaterinburg, , Russia

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Donostia / San Sebastian, Basque Country, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Songkhla, Hat Yai, Thailand

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Khon Kaen, THA, Thailand

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Bangkok, , Thailand

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Ankara, , Turkey (Türkiye)

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Bury Saint Edmonds, Suffolk, United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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United States Australia Canada China Czechia France Germany Greece Hungary Israel Italy Japan Malaysia Netherlands Puerto Rico Russia Spain Thailand Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17958

Results for CRTH258C2302 from the Novartis Clinical Trials Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1190

A Plain Language Trial Summary is available on novctrd.com

Other Identifiers

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2018-001788-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRTH258C2302

Identifier Type: -

Identifier Source: org_study_id

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