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Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

NCT ID: NCT03610646

Last Updated: 2023-03-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2021-09-10

Brief Summary

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Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.

The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

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Detailed Description

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Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects to receive the assigned treatment until Week 48.

All subjects to return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. Additional visits allowed during the study as specified in the study schedule for safety and pharmacokinetic evaluation.

Pharmacokinetics (PK) and Immunogenicity to be assessed in the subjects participating in the study.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Masked study drug kits will be supplied to sites as necessary during the study. The outside label of the box will not reveal the identity of the product inside (whether it is Eylea or MYL-1701P) and will be assigned in a masked fashion through the Interactive Response Technology (IRT) system. An un-masked team will identified at site, to be responsible for preparation and administration of the study drug.

Study Groups

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MYL-1701P

MYL-1701P

Group Type EXPERIMENTAL

MYL-1701P

Intervention Type DRUG

Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.

The additional doses may be administered in accordance with the protocol.

Eylea

Eylea

Group Type ACTIVE_COMPARATOR

Eylea

Intervention Type DRUG

Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.

The additional doses may be administered in accordance with the protocol.

Interventions

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MYL-1701P

Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.

The additional doses may be administered in accordance with the protocol.

Intervention Type DRUG

Eylea

Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.

The additional doses may be administered in accordance with the protocol.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects age ≥ 18 years.
2. Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
3. The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
4. Subject is able to understand and voluntarily provide written informed consent to participate in the study.
5. If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
6. If female, subject must be:

1. Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
2. Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment.
3. Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
8. Subject is willing to comply with the study duration, study visits and study related procedures.

Exclusion Criteria

1. Subjects with known hypersensitivity to aflibercept or any of the excipients
2. Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
3. Subjects with uncontrolled hypertension defined as systolic blood pressure \>160mm Hg or diastolic blood pressure \> 95 mm of Hg.
4. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
5. Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
6. Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Momenta Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mylan Investigator Site

Phoenix, Arizona, United States

Site Status

Mylan Investigator Site

Phoenix, Arizona, United States

Site Status

Mylan Investigator Site

Sacramento, California, United States

Site Status

Mylan Investigator Site

St. Petersburg, Florida, United States

Site Status

Mylan Investigator Site

Winter Haven, Florida, United States

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Mylan Investigator Site

Augusta, Georgia, United States

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Mylan Investigator Site

Shawnee Mission, Kansas, United States

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Mylan Investigator Site

Paducah, Kentucky, United States

Site Status

Mylan Investigator Site

Chevy Chase, Maryland, United States

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Mylan Investigator Site

Ladson, South Carolina, United States

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Mylan Investigator Site

Nashville, Tennessee, United States

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Mylan Investigator Site

Abilene, Texas, United States

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Mylan Investigator Site

Morgantown, West Virginia, United States

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Mylan Investigator Site

Prague, Vinohrady, Czechia

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Mylan Investigator Site

Hradec Králové, , Czechia

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Mylan Investigator Site

Olomouc, , Czechia

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Mylan Investigator Site

Pardubice, , Czechia

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Mylan Investigator Site

Prague, , Czechia

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Mylan Investigator Site

Prague, , Czechia

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Mylan Investigator Site

Zlín, , Czechia

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Mylan Investigator Site

Göttingen, Lower Saxony, Germany

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Mylan Investigator Site

Mainz, Rheinland-Pflaz, Germany

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Mylan Investigator Site

Marburg, , Germany

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Mylan Investigator Site

Budapest, , Hungary

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Mylan Investigator Site

Budapest, , Hungary

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Debrecen, , Hungary

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Mylan Investigator Site

Nyíregyháza, , Hungary

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Mylan Investigator Site

Pécs, , Hungary

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Mylan Investigator Site

Szeged, , Hungary

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Mylan Investigator Site

Zalaegerszeg, , Hungary

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Mylan Investigator Site

Visakhapatnam, Andhra Pradesh, India

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Mylan Investigator Site

Ahmedabad, Gujarat, India

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Mylan Investigator Site

Ahmedabad, Gujarat, India

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Mylan Investigator Site

Bangalore, Karnataka, India

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Mylan Investigator site

Bangalore, Karnataka, India

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Mylan Investigator Site

Bangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Mylan Investigator Site

New Delhi, National Capital Territory of Delhi, India

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Bhubaneswar, Odisha, India

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Mylan Investigator Site

Chandigarh, Punjab, India

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Mylan Investigator Site

Jaipur, Rajasthan, India

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Mylan Investigator Site

Madurai, Tamil Nadu, India

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Mylan Investigator Site

Tirunelveli, Tamil Nadu, India

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Mylan Investigator Site

Hyderabad, Telangana, India

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Mylan Investigator Site

Noida, Uttar Pradesh, India

Site Status

Mylan Investigator Site

Nagoya, Aichi-ken, Japan

Site Status

Mylan Investigator Site

Kōriyama, Fukushima, Japan

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Mylan Investigator Site

Sapporo, Hokkaido, Japan

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Mylan Investigator Site

Mito, Ibaraki, Japan

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Mylan Investigator Site

Yamato, Kanagawa, Japan

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Mylan Investigator Site

Susono, Shizuoka, Japan

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Mylan Investigator Site

Kofu, Yamanashi, Japan

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Mylan Investigator Site

Fukuoka, , Japan

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Mylan Investigator Site

Fukushima, , Japan

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Mylan Investigator Site

Kagoshima, , Japan

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Mylan Investigator Site

Kumamoto, , Japan

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Mylan Investigator Site

Nagasaki, , Japan

Site Status

National Hospital Organization Osaka National Hospital

Osaka, , Japan

Site Status

Mylan Investigator Site

Saitama, , Japan

Site Status

Mylan Investigator Site

Jelgava, , Latvia

Site Status

Mylan Investigator Site

Riga, , Latvia

Site Status

Mylan Investigator Site

Riga, , Latvia

Site Status

Mylan Investigator Site

Katowice, Silesian Voivodeship, Poland

Site Status

Mylan Investigator Site

Tarnów, Tarnow, Poland

Site Status

Mylan Investigator Site

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status

Mylan Investigator Site

Rzeszów, , Poland

Site Status

Mylan Investigator Site

Wałbrzych, , Poland

Site Status

Mylan Investigator Site

Lodz, Łódź Voivodeship, Poland

Site Status

Mylan Investigator Site

Kazan', Tatarstan Resp., Russia

Site Status

Mylan Investigator Site

Moscow, , Russia

Site Status

Mylan Investigator Site

Novosibirsk, , Russia

Site Status

Mylan Investigator Site

Omsk, , Russia

Site Status

Mylan Investigator Site

Saint Petersburg, , Russia

Site Status

Countries

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United States Czechia Germany Hungary India Japan Latvia Poland Russia

References

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Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Degi R, Gupta V, Kishino G, Kamei M, Loganathan S; INSIGHT Study Group. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Oct 1;142(10):952-960. doi: 10.1001/jamaophthalmol.2024.3458.

Reference Type DERIVED
PMID: 39264599 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MYL-1701P-3001

Identifier Type: -

Identifier Source: org_study_id

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