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临床试验/EUCTR2019-002738-36-DE
EUCTR2019-002738-36-DE进行中（未招募）1 期

A Double-Masked, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy of Oral AKST4290 with Loading Doses of Aflibercept in Patients with Newly Diagnosed Neovascular Age-Related Macular Degeneration (PHTHALO – 205)

Alkahest, Inc.0 个研究点目标入组 120 人开始时间: 2019年10月4日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
120
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye, as assessed by a central reader.
  • •a. Has been examined by a retinal specialist and found to be eligible to receive IAI in the study eye.
  • •b. No prior treatment for nAMD in the study eye.
  • •c. Study eye has not undergone pars plana vitrectomy or glaucoma filtering surgery.
  • •d. Participation in studies of investigational drugs must have been discontinued within 30 days or 5 half-lives of the drug (whichever was longer) prior to screening (Visit 1).
  • •e. CST thickness = 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF).
  • •f. Presence of SRF and/or IRF on SD-OCT.
  • •g. Total lesion size not greater than 12 disc areas (30.48 mm2)(1 disc area = 2.54 mm2) on FA.
  • •h. If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FP/FAF.
  • •i. No subfoveal fibrosis or atrophy on FA, SD-OCT, or FP/FAF.
  • •j. Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation.
  • •2. BCVA in the study eye between 70 and 24 letters inclusive.
  • •3. Subjects 50 years of age or older at screening (Visit 1).
  • •4. Body mass index (BMI) between 18 and = 40 at screening (Visit 1).
  • •5. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 40
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 80

排除标准

  • •Exclusion Criteria abbreviated due to 5000 character limit.
  • •1. Participation in studies of investigational drugs within 30d or 5 half-lives of the drug (whichever was longer) prior to Visit 1.
  • •2. Known hypersensitivity to the active substance or excipients of AKST4290 or aflibercept.
  • •3. Active or suspected ocular or periocular infection and/or active, severe intraocular inflammation.
  • •4. Any form of macular degeneration that is not age-related.
  • •5. Additional disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (IOP > 24) with visual field loss, clinically significant diabetic macular edema, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, high myopia > 6 diopters, or genetic disorders such as retinitis pigmentosa).
  • •6. Presence of RPE tears or rips in the study eye.
  • •7. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate visualization with FP/FAF, FA, or SD-OCT.
  • •8. Intraocular surgery in the study eye within 3 months prior to Visit 1.
  • •9. Aphakia or total absence of the posterior capsule (YAG laser capsulotomy permitted in an eye with a posterior chamber intraocular lens if performed a minimum of 1 month prior to enrollment) in the study eye.
  • •10. Known allergy to fluorescein sodium.
  • •11. WOCBP.
  • •12. Current/planned use of medications known to be toxic to retina, lens, or optic nerve.
  • •13. Medical history or condition:
  • •a. Uncontrolled Diabetes M.
  • •b. MI or stroke within 12 months of Visit 1.
  • •c. Active bleeding disorder.
  • •d. Major surgery within 1 month of Visit 1 or planned within study period.
  • •e. Current, active liver disease: > 3-fold ULN for ALT and AST.
  • •f. Uncontrolled high BP (systolic >= 160 mmHg and/or diastolic >= 100 mmHg) despite treatment during the 3 months prior to dosing.
  • •g. Positive HBV, HCV, HIV at Visit 1.
  • •14. Prior treatment within 4 weeks or planned use of potent CYP450 3A4/5 (CYP3A4/5) or P-glycoprotein (P-gp) inhibitors or inducers during study.
  • •15. Planned concomitant use of CYP3A4/5 and/or P-gp sensitive substrates with narrow therapeutic index (e.g., digoxin, warfarin, factor Xa inhibitors) (see Section 17.2.1).
  • •16. Planned concomitant use of CYP3A4/5 sensitive substrates for which an increase in plasma levels could be clinically significant, such as fentanyl, simvastatin, lovastatin, atorvastin (see Section 17.2.1).
  • •17. Planned concomitant use of drugs with a narrow therapeutic window that are metabolized predominantly by CYP2C8, or are CYP2C8 sensitive substrates for which an increase in plasma levels could be clinically significant.
  • •18. Planned concomitant use of drugs with a narrow therapeutic window that are metabolized predominantly by CYP2C9 should be excluded, and caution for CYP2C9 sensitive substrates.
  • •19. Planned concomitant use of OAT1 and OAT3 sensitive substrates for which an increase in plasma levels could be clinically significant.
  • •20. Planned concomitant use of BCRP sensitive substrates for which an increase in plasma levels could be clinically significant.
  • •21. Renal function as defined by estimated eGFR < 45 mL/min/1.73 m2 using the MDRD study equation and/or renally impaired patients (eGFR = 60) with planned concomitant use of OCT2 substrates with a narrow therapeutic index or OCT2 inhibitors.
  • •22. Use of any nonselective MAO inhibitors (MAOI-Bs are acceptable).
  • •23. Use of systemic corticosteroids (> 10 mg prednisone or equivalent/d) within 14 d of 1st dose of study agent or known diseases whic

研究者

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