Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: MYL-1701P Pre-filled Syringe: Subjects will receive 1 dose of 2 mg at Baseline through intravitreal injection
Control Intervention1: Not applicable: Not applicable
Sponsors
Biosimilar collaborations Ireland Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subject =18 years of age who have nAMD, DME, macular edema following RVO, or DR in the study eye. 2. Study eye requires treatment with aflibercept as per Investigator’s discretion. 3. If female of childbearing potential, the subject must have a negative urine pregnancy test at the screening and baseline visits and should not be nursing or planning a pregnancy. 4. If female, subject must be: a. Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or b. Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting from screening and continuing at least 90 days following the study drug administration. c. Of non-childbearing potential (i.e., post-menopausal for at least 1 year). 5. If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #4b) or abstain from sexual relations during the study period and up to 90 days following the study drug administration. 6. Subject is willing to comply with the study visits and study related procedures. 7. Subject is able to understand and voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Subject with known hypersensitivity to aflibercept or any of the excipients in MYL-1701P. 2. Subject on treatment with any intravitreal injection in the study eye within the 28 days prior to Day 1. 3. Subject with intraocular pressure = 25 mmHg in study eye. 4. Subject with any intraocular surgery in the study eye at any time during the past 3 months prior to Day 1. 5. Subject with evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye. 6. Subject with any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injections with any agent in either eye. 7. Subject with history of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after intravitreal injection or intraocular procedures in either eye. 8. Subject with clinical diagnosis of uncontrolled glaucoma (defined as intraocular pressure = 25 mmHg despite treatment with antiglaucoma medication). 9. Use of therapies that are known to be toxic to any ocular tissues (i.e., radiation) in either eye anytime in the past. 10. Subject taking any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational including steroids) in the study eye. 11. Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm of Hg. 12. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment. 13. Subjects with renal failure requiring dialysis or renal transplant. 14. Subject having any concurrent systemic condition or any ocular condition in the study eye which, in the opinion of the investigator, could have either increased the risk to the subject beyond what was to be expected from standard procedures of intravitreal injections, or which otherwise may have interfered with the injection procedure or with evaluation of safety. 15. Subject participation in any interventional clinical study within the 12 weeks prior to day 1 of the study. 16. Subject with current systemic infectious disease or a therapy foractive infectious disease. 17. Subject who has only one functional eye, even if the eye met all other study requirements, or who has an ocular condition on the fellow eye with a poorer prognosis than the study eye. 18. Current known active infection of coronavirus disease 2019 (COVID-19), or subjects with an increased risk of serious COVID-19 related morbidity as determined by the investigator at the time of screening and/or enrollment; subjects who have had previous COVID-19 infections but have recovered by the time of enrollment visit may be enrolled if there are no current COVID-19 symptoms as determined by the investigator; subjects who had previously received COVID-19 vaccine may be enrolled irrespective of the timing of vaccination. (Additional COVID-19 screening procedures that may be mandated by the study site do not need to be reported as protocol deviations).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment emergent adverse events (TEAEs). Timepoint: day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to determine if the presentation MYL-1701P PFS can be used effectively by Ophthalmologists to administer the 2 mg dose of MYL-1701P. Timepoint: 1 Day | — |
Countries
India, United States of America
Contacts
Public ContactJayanti Panda
Biocon Biologic Limited,
Outcome results
None listed