Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: MYL-1701P; Eylea
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to either MYL-1701P or Eylea groups in parallel for the duration of the study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema,; BCVA,; ETDRS Letters.

Summary:

      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.
    

Eligibility criteria:

        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).

          7. 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.

          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.