Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: MYL-1701P: Subjects will receive 3 doses each of 2 mg at 8 weeks interval
Control Intervention1: NIL: NIL
Sponsors
Mylan Inc
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject participated in the MYL-1701P-3001 study 2.Subject requires treatment with intravitreal anti-VEGF therapy 3.Subject is able to understand and voluntarily provide written informed consent to participate in the study. 4.If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy. 5.Subject is willing to comply with the study duration, study visits and study related procedures. 6.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 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
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to aflibercept or any of the excipients 2. 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. 3. Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye. 4. Subjects who plan to participate in another clinical study while enrolled in this study. 5. Subjects receiving treatment for a serious systemic infection. 6. Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg. 7. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment visit. 8. Subjects with renal failure requiring dialysis or renal transplant. 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment emergent adverse events (TEAEs).Timepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVATimepoint: Week 20;Change from baseline in CRTTimepoint: Weeks 8, 16 and 20 | — |
Countries
India
Contacts
Public ContactRajesh S Nachankar
Mylan Pharmaceuticals Pvt Ltd.
Outcome results
None listed