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OLISENS-ANIRIDIA
EU CTIS ID: 2025-522609-39-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.