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Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT ID: NCT03481634

Last Updated: 2023-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2021-10-18

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 visual impairment due to diabetic macular edema (DME).

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Detailed Description

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This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100.

Subjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase.

Disease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study.

To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brolucizumab 3 mg

Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule.

To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).

Group Type EXPERIMENTAL

Brolucizumab

Intervention Type DRUG

Intravitreal injection

Brolucizumab 6 mg

Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule.

To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).

Group Type EXPERIMENTAL

Brolucizumab

Intervention Type DRUG

Intravitreal injection

Aflibercept 2 mg

Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks.

To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

Intravitreal injection

Interventions

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Brolucizumab

Intravitreal injection

Intervention Type DRUG

Aflibercept

Intravitreal injection

Intervention Type DRUG

Other Intervention Names

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RTH258 ESBA1008 Eylea

Eligibility Criteria

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Inclusion Criteria

* Written informed consent before any assessment
* Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
* Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study

Exclusion Criteria

* Active proliferative diabetic retinopathy in the study eye
* Active intraocular or periocular infection or active intraocular inflammation in study eye
* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
* Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
* Stroke or myocardial infarction during the 6-month period prior to baseline
* Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
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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Beverly Hills, California, 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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Danbury, Connecticut, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Stuart, Florida, United States

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‘Aiea, Hawaii, United States

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Urbana, Illinois, United States

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Wheaton, Illinois, 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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Paducah, Kentucky, United States

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Springfield, Massachusetts, United States

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Stoneham, Massachusetts, United States

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Reno, Nevada, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Kingston, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, 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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Harlingen, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Silverdale, Washington, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Ciudad Autonoma de Bs As, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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CABA, , Argentina

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CABA, , Argentina

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Córdoba, , Argentina

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Liverpool, New South Wales, Australia

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Parramatta, New South Wales, Australia

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Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

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Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Graz, , Austria

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Innsbruck, , Austria

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Vienna, , Austria

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, , Canada

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Medellín, Antioquia, Colombia

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Medellín, Antioquia, Colombia

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Bogotá, , Colombia

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Haifa, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , 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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Chieti, CH, Italy

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Catania, CT, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Padua, PD, Italy

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Roma, RM, Italy

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Kurume, Fukuoka, Japan

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Amagasaki, Hyōgo, Japan

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Tsuchiura, Ibaragi, Japan

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Ishioka, Ibaraki, Japan

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Kagoshima, Kagoshima-ken, Japan

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Matsumoto, Nagano, Japan

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Saitama-shi, Saitama, Japan

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Shimotsuke, Tochigi, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Taito-ku, Tokyo, Japan

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Kumamoto, , Japan

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Osaka, , Japan

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Amsterdam, , Netherlands

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Rotterdam, , Netherlands

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Tilburg, , Netherlands

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Coimbra, , Portugal

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Coimbra, , Portugal

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Leiria, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Santa Maria da Feira, , Portugal

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Vila Franca de Xira, , Portugal

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Arecibo, , Puerto Rico

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Valladolid, Castille and León, Spain

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Barcelona, Catalonia, Spain

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Sant Cugat del Vallès, Catalonia, Spain

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Valencia, Valencia, Spain

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Barcelona, , Spain

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Zaragoza, , Spain

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Frimley, Surrey, United Kingdom

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Birmingham, , United Kingdom

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Hull, , United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Argentina Australia Austria Canada Colombia Israel Italy Japan Netherlands Portugal Puerto Rico Spain 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/patientsummary/patientsummaries?patientSummaryId=1194

A Plain Language Trial Summary is available on novctrd.com

Other Identifiers

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2017-004742-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRTH258B2301

Identifier Type: -

Identifier Source: org_study_id

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