NL-OMON48871撤回不适用
A safety study of intravitreal PP-001 in patients with chronic, non-infectious uveitis having chronic inflammation - PP-001-1001
Panoptes Pharma0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 5
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 99（—）
入选标准
- •1. Male or female patients at the age of 18 years and older who have diagnosis
- •of chronic posterior uveitis, intermediate uveitis or panuveitis.
- •2. Good general state of health (mentally and physically). Laboratory
- •parameters and vital signs of patients must be within the normal ranges.
- •3. A signed and dated written informed consent form.
- •4. A signed and dated written data protection consent form.
- •5. Female patients of childbearing potential must perform a negative urine
- •pregnancy test prior to the injection on the day of the injection visit (Day 0).
- •6. Male and female patients must ensure that one highly effective method
- •combined with an acceptable method of contraception is used for the entire
- •duration of the study, from first dose up to the study follow-up visit, and
- •refrain from becoming pregnant or fathering a child in the 3 months following
- •the last study drug administration. Male patient must agree with their female
- •partners prior to screening to use the above specified methods of contraception
- •while receiving protocol-specified medication, and for 3 months after stopping
- •the medication
- •7. Have diagnosis of chronic posterior uveitis, intermediate uveitis or
- •panuveitis (as defined by the Standardization of Uveitis Nomenclature Working
- •Group [Jabs et al., 2005]) in at least one eye. For patients with panuveitis,
- •the anterior component of inflammation must be less than the posterior
- •component. The investigator to his best knowledge must rule out any suspected
- •masquerade syndrome or infection prior to study entry.
- •8. Have chronic, posterior uveitis, intermediate uveitis or panuveitis
- •requiring treatment.
- •9. Have media clarity, pupillary dilation and patient cooperation sufficient
- •for adequate visualization of the optic nerve in the study eye.
- •10. Have been receiving an adequate therapy of e.g. systemic corticosteroid
- •treatment or immunosuppressive therapy (e.g. azathioprine, methotrexate,
- •cyclosporine, mycophenolate, tacrolimus) or any combination thereof. Any
- •systemic therapy at study start should be continued throughout the study.
- •11. Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual
- •acuity of 10 letters or better (approximately 1/35 or 0.032) but equal or less
- •than 70 letters (approximately 20/40 or 0.5) in the study eye
- •12. Best-corrected ETDRS visual acuity of 34 letters or better in the fellow
- •eye (approximately 20/200 or 0.1)
排除标准
- •1. Patients in whom media opacities (cornea, anterior or posterior synechia,
- •cataract, vitreous haze and others) of either eye preclude investigation and
- •documentation of the posterior pole and intravenous fluorescein angiography, or
- •optical coherence tomography evaluation in the study eye.
- •2. Patients receiving any local biologicals.
- •3. Treatment with cyclophosphamide or chlorambucil.
- •4. Intravitreal injections (including but not limited to anti-vascular
- •endothelial growth factors) 60 days prior to the baseline.
- •5. Posterior subtenon's injection or orbital floor injection of steroids 90
- •days prior to Baseline.
- •6. Any implantable corticosteroid-eluting device (Ozurdex, Iluvien, Retisert,
- •triamcinolone intravitreal implant, fluocinolone intravitreal implant) in the
- •study eye, with the following exceptions:
- •* If the device had been removed more than 90 days prior to Day 0 of this
- •study, the eye will be eligible for PP-001-1001.
- •* If Ozurdex had been implanted 6 months before Day 0 of this study, the eye
- •will be eligible for PP-001-1001.
- •* If Iluvien or Retisert had been implanted 3 years before Day 0 of this study,
- •the eye will be eligible for PP-001-1001.
- •7. Intraocular surgery within 90 days prior to Day 0 in the study eye.
- •8. Capsulotomy within 30 days prior to Day 0 in the study eye.
- •9. History of vitreoretinal surgery or scleral buckling within 90 days prior to
- •Day 0 in the study eye.
- •10. Any ocular surgery (including cataract extraction or capsulotomy) of the
- •study eye anticipated within the first 60 days following Day 0.
- •11. Intraocular pressure (IOP) *25 mmHg in the study eye (glaucoma patients
- •maintained on no more than one topical medication with IOP <25 mmHg are allowed
- •to participate).
- •12. Ocular hypotonia (IOP less than 6 mmHg).
- •13. Pupillary dilation inadequate for quality fundus photography in the study
- •14. Aphakia or anterior chamber lens in the study eye.
- •15. Visible scleral thinning, scleral ectasia or keratoconus in the study eye.
- •16. Presence of any ocular malignancy.
- •17. Ocular or periocular infection in either eye or the use of systemic
- •antibiotics.
- •18. Participation in other investigational drug or device clinical trials
- •within 90 days prior to Day 0, or planning to participate in other
- •investigational drug or device clinical trials within 180 days following Day 0.
- •This includes both ocular and non-ocular clinical trials.
- •19. Female patients who are pregnant, nursing, or planning a pregnancy, or who
- •are of childbearing potential and not willing to use reliable means of
- •contraception.
- •20. Use of any anticoagulant or thrombocyte aggregation inhibiting agent
- •(marcumar, warfarin, heparin, enoxaparin, apixaban, rivaroxaban,
- •pentosanpolysulfate, dabigatran) less than 7 days prior to injection visit (Day
- •21. Known allergy or hypersensitivity to the study medication, any component of
- •the delivery vehicle, any corticosteroids or any diagnostic agents used during
- •the study (e.g., fluorescein, dilation drops, antibiotic drops, povidone).
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