Status:
COMPLETED
Extension Study of MYL-1701P-3001 for Safety and Efficacy
Lead Sponsor:
Mylan Pharmaceuticals Inc
Collaborating Sponsors:
Momenta Pharmaceuticals, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 thes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04674800
Start Date
November 23 2020
End Date
April 20 2022
Last Update
August 26 2022
Active Locations (15)
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1
Mylan Investigative site
Hyderabad, Andhra Pradesh, India, 500034
2
Mylan Investigative Site
Visakhapatnam, Andhra Pradesh, India, 530 040
3
Mylan Investigative Site
Ahmedabad, Gujarat, India, 380015
4
Mylan Investigative site
Ahmedabad, Gujarat, India, 380016