- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674800
Extension Study of MYL-1701P-3001 for Safety and Efficacy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New Delhi, India, 110029
- Mylan Investigative site
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
- Mylan Investigative site
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Visakhapatnam, Andhra Pradesh, India, 530 040
- Mylan Investigative site
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Gujarat
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Ahmedabad, Gujarat, India, 380015
- Mylan Investigative site
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Ahmedabad, Gujarat, India, 380016
- Mylan Investigative site
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Karnataka
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Bangalore, Karnataka, India, 560 010
- Mylan Investigative site
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Bangalore, Karnataka, India, 560094
- Mylan Investigative site
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Bengaluru, Karnataka, India, 560037
- Mylan Investigative site
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Maharastra
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Mumbai, Maharastra, India, 400050
- Mylan Investigative site
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Odisha
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Bhubaneswar, Odisha, India, 751024
- Mylan Investigative site
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Punjab
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Chandigarh, Punjab, India, 160012
- Mylan Investigative site
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Rajasthan
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Jaipur, Rajasthan, India, 302015
- Mylan Investigative site
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Tamil Nadu
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Madurai, Tamil Nadu, India, 625 020
- Mylan Investigative site
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Tamilnadu
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Tirunelveli, Tamilnadu, India, 627002
- Mylan Investigative site
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Uttar Pradesh
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Noida, Uttar Pradesh, India, 201301
- Mylan Investigative site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single, test arm
MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
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Open label and single arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment emergent adverse events (TEAEs).
Time Frame: Week 20
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Number of participants with TEAEs
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Week 20
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in BCVA
Time Frame: Weeks 8, 16 and 20
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Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
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Weeks 8, 16 and 20
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Change from baseline in CRT
Time Frame: Weeks 8, 16 and 20
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Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
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Weeks 8, 16 and 20
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Prasanna Ganapathi, MD, Mylan Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFIL-IJZ-3002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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