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

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID: NCT03610646
Run by: Mylan Pharmaceuticals Inc
People needed: 355
Starts: 2018-08-23
Expected to finish: 2021-09-10
Last updated by the study team: 2023-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects age ≥ 18 years.
Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
Subject is able to understand and voluntarily provide written informed consent to participate in the study.
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.
If female, subject must be:
Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
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.
Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
Subject is willing to comply with the study duration, study visits and study related procedures.

You may not qualify if…

Subjects with known hypersensitivity to aflibercept or any of the excipients
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
Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
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
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.

Where it is running

Mylan Investigator Site — Phoenix, Arizona, United States
Mylan Investigator Site — Sacramento, California, United States
Mylan Investigator Site — St. Petersburg, Florida, United States
Mylan Investigator Site — Winter Haven, Florida, United States
Mylan Investigator Site — Augusta, Georgia, United States
Mylan Investigator Site — Shawnee Mission, Kansas, United States
Mylan Investigator Site — Paducah, Kentucky, United States
Mylan Investigator Site — Chevy Chase, Maryland, United States
Mylan Investigator Site — Ladson, South Carolina, United States
Mylan Investigator Site — Nashville, Tennessee, United States
Mylan Investigator Site — Abilene, Texas, United States
Mylan Investigator Site — Morgantown, West Virginia, United States
Mylan Investigator Site — Prague, Vinohrady, Czechia
Mylan Investigator Site — Hradec Králové, Czechia
Mylan Investigator Site — Olomouc, Czechia
Mylan Investigator Site — Pardubice, Czechia
Mylan Investigator Site — Prague, Czechia
Mylan Investigator Site — Prague, Czechia
Mylan Investigator Site — Zlín, Czechia
Mylan Investigator Site — Göttingen, Lower Saxony, Germany
Mylan Investigator Site — Mainz, Rheinland-Pflaz, Germany
Mylan Investigator Site — Marburg, Germany
Mylan Investigator Site — Budapest, Hungary
Mylan Investigator Site — Budapest, Hungary
Mylan Investigator Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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