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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Biological: MYL-1701P, a proposed biosimilar to Eylea


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single, test arm<br>MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval | Biological: MYL-1701P, a proposed biosimilar to Eylea<br>* Open label and single arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment emergent adverse events (TEAEs). | Number of participants with TEAEs | Week 20 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema, BCVA, ETDRS Letters