Extension Study of MYL-1701P-3001 for Safety and Efficacy

Phase 3

Completed

Brief Summary: This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

Detailed Description: Diabetic retinopathy is an important cause of blindness worldwide. The International Diabetes Federation estimates that 285 million people worldwide have diabetes mellitus and approximately 7% of these individuals are affected by diabetic macular edema.

EYLEA® (aflibercept) injection, an anti-Vascular Endothelial Growth Factor (VEGF) agent, has been approved by the FDA and EMA for the treatment of Diabetic Macular Edema (DME).

Mylan Inc. and Momenta Pharmaceuticals, Inc. are developing MYL-1701P, a proposed biosimilar to Eylea.

MYL-1701P-3001 study was designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of MYL-1701P in the treatment of subjects with Diabetic Macular Edema (DME). Eligible subjects from MYL-1701P-3001 study will be enrolled in the AFIL-IJZ-3002 study. All enrolled subjects will receive three doses of MYL-1701P every eight weeks. Subjects will attend the clinic visits for safety and efficacy assessments including BCVA, SD-OCT, complete ophthalmological examinations during the study.

Recruitment & Eligibility

Inclusion Criteria

Subject participated in the MYL-1701P-3001 study
Subject requires treatment with intravitreal anti-VEGF therapy
Subject is able to understand and voluntarily provide written informed consent to participate in the study.
If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
Subject is willing to comply with the study duration, study visits and study related procedures.
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
- Of non-childbearing potential
If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control

Exclusion Criteria

Subjects with known hypersensitivity to aflibercept or any of the excipients
Subjects will be excluded if any of the following conditions are met in the study eye:
- Subjects with active ocular inflammation.
- Subjects with uncontrolled glaucoma
- Surgery for glaucoma in the past or likely to be needed in the future.
Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
Subjects who plan to participate in another clinical study while enrolled in this study.
Subjects receiving treatment for a serious systemic infection.
Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg.
Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
Subjects with renal failure requiring dialysis or renal transplant.
Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.

Arm && Interventions

Group	Intervention	Description
Single, test arm	MYL-1701P, a proposed biosimilar to Eylea	MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment emergent adverse events (TEAEs).	Week 20	Number of participants with TEAEs

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA	Weeks 8, 16 and 20	Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Change from baseline in CRT	Weeks 8, 16 and 20	Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)