CTIS2023-503931-17-00招募中1 期
PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study) - LBS-008-CT05
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 429
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Subjects must be willing and able to provide signed informed consent prior to participation in any study-related procedures., 2. Males or females, 60 to 85 years of age., 3. Subjects must have a confirmed diagnosis of GA with atrophic lesions (diagnosed as GA) in 1 or both eyes, measuring 1 to 10 mm2 in aggregate area as assessed by FAF photography and determined by a central reading center. - For lesions with foveal involvement, BCVA in the study eye should be 20/80 or better (= 54 ETDRS letters) - For lesions without any foveal involvement, BCVA in the study eye should be 20/100 or better (= 49 ETDRS letters) - No minimum BCVA is required in the fellow eye, 4. Ability to adequately examine the study eye fundus at enrollment (the subject must have sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and the ability to cooperate sufficiently for adequate ophthalmic visual function testing)., 5.Female subjects must be nonpregnant and nonlactating. Male subjects whose partners are fertile, and women of childbearing potential (WOCBP) must use only highly effective contraception methods for the entire study duration and not donate sperm or eggs throughout the entire study from the date of informed consent until 89 days (WOCBP) or 149 days (men) after the last dose of the study treatment in case of early treatment termination.
排除标准
- •1. Any GA lesions larger than 10 mm2 in the study eye., 6. Presence or history of choroidal neovascularization (CNV) in the study eye as determined by optical coherence tomography angiography (OCT-A) and confirmed by a central reading center. If OCT-A results are inconclusive to confirm the presence/absence of CNV, as determined by central imaging center, fluorescein angiography may be performed at the discretion of the Study Investigator., 7. Inflammatory disease of the retina, uvea, or choroid in either eye within 1 year of study enrollment., 8. Any form of uncontrolled glaucoma in the study eye based on the criteria below assessed at Screening: - Intraocular pressure > 25 mm Hg - Glaucomatous visual field, or disc cupping considered clinically significant (CS) for advanced glaucoma (cup to-disc ratio > 0.6)., 9. Severe dry eye disease., 14. Any prior or current use of retinotoxic drugs., 15. Investigational drug use of any kind in the previous 3 months., 16. Any prior ocular gene therapy., 17. Any prior intraocular, periocular, or intravitreal injection of any drug in the study eye in the previous 6 months., 18. Prior macular laser photocoagulation treatment or any history of photodynamic therapy in the study eye. Prior extramacular laser photocoagulation treatment is allowed, but not within 1 year prior to enrollment in the study., 19. Use of any known drugs or supplements that are inhibitors/inducers of cytochrome P450 enzymes (e.g., Clarithromycin, Fluvoxamine, Ketoconazole, Rifampin, Carbamazepine, St. John’s wort) starting within 30 days of first study treatment administration, or regular consumption of foods that are inhibitors/inducers of cytochrome P450 enzymes (e.g., grapefruit, pomegranate, star fruit, bitter orange [Seville orange]) starting within 48 hours of first study treatment administration that, in the investigator’s judgment, may impact subject safety or the validity of the study results., 10. Myopia > -8 D in the study eye., 20. Use of proton pump inhibitors (gastric acid reducing agents) that cannot be stopped within 2 weeks prior to the first study treatment dose and during the study (e.g., omeprazole, esomeprazole, pantoprazole) and cannot be switched into histamine 2-receptor antagonists., 21. Use of breast cancer resistance protein inhibitors that cannot be stopped within 30 days prior to the first study treatment dose and during the study (e.g., Cyclosporine A, Darolutamide, Fostamatinib)., 22. Presence of life-threatening disease(s), including malignancies requiring current treatment., 23. Abnormal cardiac rhythm not controlled with medication or history of stroke, coronary events, and/or heart failure within 1 year prior to enrollment., 24. Uncontrolled hypertension as defined by blood pressure = 160 systolic or = 100 diastolic (note: investigator to take the better of at least 2 measurements)., 25. Alanine aminotransferase/aspartate aminotransferase > 2.5 × the upper limit of normal., 26. Previous diagnosis of Moderate, Severe, or End Stage kidney disease (Stages 3B – 5), or current use of medications to manage cardiovascular risk associated with chronic kidney disease., 27. Body mass index = 40., 28. Hemoglobin A1c = 8%., 29. Unwillingness or inability to provide signed informed consent prior to participation in any study-related procedures., 11. Hypermetropia > +8 D in the study eye., 30. Pregnant or nursing female subjects; women of childbearing potential who are unwilling or unable to use an acceptab
研究者
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