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临床试验/EUCTR2019-002738-36-HU
EUCTR2019-002738-36-HU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 150 人开始时间: 2019年9月19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
150
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. No previous participation in any studies of investigational drugs within 1 month preceding 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 on FA.
  • •h. If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA.
  • •i. No subfoveal fibrosis or atrophy on FA.
  • •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 at screening (Visit 1).
  • •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 50
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 100

排除标准

  • •1. Previous participation in any studies of investigational drugs within 1 month preceding screening.
  • •2. Any form of macular degeneration that is not age-related.
  • •3. Additional disease in the study eye that could compromise BCVA.
  • •4. Presence of RPE tears or rips in the study eye.
  • •5. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate visualization with fundus photography/FA or SD-OCT.
  • •6. Intraocular surgery in the study eye within 3 months prior to screening.
  • •7. Aphakia or total absence of the posterior capsule (yttrium aluminum garnet [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.
  • •8. Known allergy to fluorescein sodium.
  • •9. Women of childbearing potential (WOCBP).
  • •10. Current or planned use of medications known to be toxic to the retina, lens, or optic nerve.
  • •11. Medical history or condition:
  • •a. Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 8%.
  • •b. Myocardial infarction or stroke within 12 months of screening.
  • •c. Active bleeding disorder.
  • •d. Major surgery within 1 month of screening or planned within the study period.
  • •e. Current, active liver disease: > 3-fold elevation of liver enzymes over upper limit of normal [ULN].
  • •f. Uncontrolled high blood pressure.
  • •g. Positive test result for hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis (by QuantiFERON testing) at screening.
  • •12. Prior treatment within 4 weeks or planned use of potent cytochrome P450 3A4/5 (CYP3A4/5) or P glycoprotein (P-gp) inhibitors or inducers during the study.
  • •13. Planned concomitant use of CYP3A4/5 and/or P-gp sensitive substrates that have a narrow therapeutic index.
  • •14. Planned concomitant use of CYP3A4/5 sensitive substrates, such as fentanyl.
  • •15. Planned concomitant use of drugs with a narrow therapeutic window that are metabolized predominantly by CYP2C8, or are CYP2C8 sensitive substrates .
  • •16. Planned concomitant use of Organic Anion Transporter 1 (OAT1) and OAT3 sensitive substrates.
  • •17. Subjects with renal impairment AND with current or planned concomitant use of organic cation transporter 2 (OCT2) substrates with a narrow therapeutic index or OCT2 inhibitors.
  • •18. Subjects with renal impairment eGFR < 45 mL/min/1.73m2 who are NOT on metformin.
  • •19. Use of any nonselective monoamine oxidase inhibitors (MAOIs) (MAOI-Bs are acceptable).
  • •20. Use of systemic corticosteroids (> 10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases which could require the use of systemic corticosteroids within the study period.
  • •21. Use of intravitreal or implanted corticosteroids:
  • •a. Dexamethasone or triamcinolone within 6 months prior to screening.
  • •b. Fluocinolone within 48 months prior to screening.
  • •22. Subjects with clinically relevant, abnormal screening hematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. Laboratory testing may be repeated once during the screening phase.
  • •23. Significant alcohol or drug abuse within the past 2 years.
  • •24. Based on electrocardiogram (ECG) reading, subjects with a risk of QT prolongation including:
  • •a. A baseline prolongation of QTc with confirmation on a repeat ECG.
  • •b. A history of additional risk factors for Torsades de pointes arrhythmia.
  • •c. The use of concomitant medications known to prolong the QT/QTc interval.

研究者

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