CTRI/2023/10/059113
Completed
Phase 3
A Multi-Center Study to Evaluate Ocular Safety and Effective Administration of MYL-1701P Pre-filled Syringe in Patients with Conditions requiring Intravitreal Aflibercept. - NI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: H36- Retinal disorders in diseases classified elsewhere
- Sponsor
- Biosimilar collaborations Ireland Limited
- Enrollment
- 35
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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