2025-522609-39-00招募中2 期
Antisense Oligonucleotide Eye Drops Against IRS-1 to Treat Pathological Corneal Neovascularisation in Aniridia-Associated Keratopathy (Olisens-Aniridia)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relative change of corneal area covered by CoNV assessed by digital standardized slit lamp images and an independent reading center.
研究概览
简要总结
Primary objective is to prove the efficacy of Olisens, an antisense oligonucleotide eye drop formulation against IRS-1 in halting/reducing CoNV in eyes with CoNV in AAK as measured in reduction of percentage of vascularized corneal area.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Pathologically vascularized cornea due to aniridia-associated keratopathy
- •Male and female patients ≥ 12 years old
- •Written informed consent from the patients and parents and/or legal guardian has been obtained prior to any trial-related procedures
- •Patient has confirmed diagnosis of aniridia and progressive corneal neovascularization (confirmed either through 2 slit-lamp photographs with at least 4 weeks apart or through clinical situation) and/or diagnosis of Stage 2 aniridia-associated keratopathy
- •At least 2 mm diameter centrally clear cornea without vessels
- •Absence of other clinical contraindications to any part or product of the treatment plan
- •A cooperative attitude to follow up the trial procedures
- •In case of bilateral disease only one eye will be included
排除标准
- •Active or suspected intraocular inflammation
- •Pregnant women and nursing mothers as trial medication has not been tested in these subjects before
- •Persons held in an institution by legal or official order
- •Use of autologous or allogenous serum eye drops during the trial period (have to be stopped 14 days ahead of enrolment into the trial)
- •Failure to use highly-effective contraceptive methods (for women of childbearing potential and males who have a partner of childbearing potential) during the study period.. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective: Oral hormonal contraception (‘pill’), Dermal hormonal contraception, Vaginal hormonal contraception (NuvaRing®), Contraceptive plaster, Long-acting injectable contraceptives, Implants that release progesterone (Implanon®), Tubal ligation (female sterilisation), Intrauterine devices that release hormones (hormone spiral), Avoiding sexual activities that could lead to pregnancy
- •Active corneal ulceration
- •Clinically significant or unstable concurrent disease or other medical condition. The possibility of a previously undiagnosed nephroblastoma (Wilms tumour) in schoolchildren and adolescents must already have been ruled out.
- •Rheumatic diseases that require systemic treatment
- •Patients unlikely to comply with the trial protocol or unable to understand the nature and scope of the trial or the possible benefits or unwanted effects of the trial procedures and treatments
- •Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit
- •Known abuse of alcohol, drugs, or medicinal products
- •Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the subject’s compliance, or place the subject at high risk of complications related to the treatment
- •Employees of the sponsor, or employees or relatives of the investigator
结局指标
主要结局
Relative change of corneal area covered by CoNV assessed by digital standardized slit lamp images and an independent reading center.
Relative change of corneal area covered by CoNV assessed by digital standardized slit lamp images and an independent reading center.
次要结局
- Visual acuity (BCVA) measured by ETDRS charts (transformed to logMAR)
- Glare visual acuity measured by ETDRS charts (transformed to logMAR)
- Vision related quality of life assessed by overall score of NEI-VFQ25 and overall score of Aniridia-Net questionnaire
- Intraocular pressure measured by I Care or Goldmann applanation tonometry, reported as mmHg
- Ocular Surface Staining measured by Oxford Grading Scale (Grades 0-5)
- Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participant
- Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2)
- Vessel Morphometry measured by vessel thickness, vessel length, vessel regression, vessel recurrence
- Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Asessment Survey (OPAS)
- Aniridia-Associated Keratopathy Grading measured by Lagali Aniridia Associated Kerathopathy Grading
- Retinal adverse events (Optical Coherence Tomography)
- Active infectious keratitis or corneal ulceration assessed by slit lamp examination
研究者
Claus Cursiefen
Scientific
University Of Cologne
研究点 (1)
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