CTRI/2023/10/059113已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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).
研究者
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