EUCTR2017-004358-40-LVActive, not recruitingPhase 1
A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Mylan Inc
- Enrollment
- 324
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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