Diabetic macular edema MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Sponsors
Mylan Inc
Eligibility
Sex/Gender
All
Inclusion 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: a. Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or b. 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. c. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical equivalence of MYL-1701P and Eylea over 8 weeks of treatment at doses and regimen recommended by the Prescribing Information for Eylea, as assessed by change from baseline to week 8 in best corrected visual acuity (BCVA).;Secondary Objective: • To compare the efficacy of MYL-1701P and Eylea as measured by change in CRT over time • To compare the efficacy of MYL-1701P and Eylea as measured by change in BCVA over time • To compare safety, tolerability, pharmacokinetics, and immunogenicity over time of MYL-1701P and Eylea • To compare the number of administrations of study drug required over the treatment period • To compare impact of immunogenicity on efficacy and safety;Primary end point(s): The primary efficacy endpoint will be the mean change from baseline in BCVA as assessed by ETDRS letters at week 8.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The mean change from baseline in CRT as determined by spectral-domain-optical coherence tomography (SD-OCT) over time • The mean change in BCVA over time • Proportion of subjects who gained =15 letters from Baseline in BCVA, assessed in change from baseline in ETDRS letters over time • Number of administrations of study drug required;Timepoint(s) of evaluation of this end point: Various timepoints as detailed in the Schedule of Activities in the protocol | — |
Countries
Czech Republic, Germany, Hungary, Japan, Latvia, Poland, United States
Contacts
Public ContactKetty Belizaire
Mylan Inc
Outcome results
None listed