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Antisense Oligonucleotide Eye Drops against IRS-1 to Optimize Pretransplant Lymphangio-regression Prior to High-Risk Keratoplasty (Olisens-Precon)
EU CTIS ID: 2025-522099-10-00
What this study is testing
Evaluate the efficacy of antisense oligonucleotide eye drops against IRS-1 (Olisens) in the treatment of pathological neovascularization due to herpetic keratopathy in combination with physical angioregressive treatment using corneal crosslinking.
- 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 prevascularized cornea due to herpetic keratopathy (diagnosis either through virology or clinical findings) with need for corneal transplantation
- Written informed consent by participant and/or witness prior to any study-related procedures
- Adult male and female participants ≥ 18 years old
- ≥ 2 corneal quadrants covered by pathological corneal neovascularization due to herpetic keratitis
- Absence of other clinical contraindications to any part or product of the treatment plan
- A cooperative attitude to follow up the study procedures
You likely can't join if
- < 2 corneal quadrants covered by pathological neovascularization
- Use of autologous or allogenous serum eye drops during study period (have to be stopped 14 days prior to trial start)
- Corneal stromal thickness below 400 μm (unless not affecting more than 50% of the corneal surface area)
- Active or suspected intraocular inflammation
- Active corneal ulceration
- Dysregulated glaucoma with IOP values > 25 mmHg despite local therapy
See the full eligibility criteria
- Pathologically prevascularized cornea due to herpetic keratopathy (diagnosis either through virology or clinical findings) with need for corneal transplantation
- Written informed consent by participant and/or witness prior to any study-related procedures
- Adult male and female participants ≥ 18 years old
- ≥ 2 corneal quadrants covered by pathological corneal neovascularization due to herpetic keratitis
- Absence of other clinical contraindications to any part or product of the treatment plan
- A cooperative attitude to follow up the study procedures
- In case of bilateral disease only one eye will be included (the responsible investigator will decide based on which eye is more affected)
- High-risk eye on the waitlist for a corneal transplantation
- < 2 corneal quadrants covered by pathological neovascularization
- Use of autologous or allogenous serum eye drops during study period (have to be stopped 14 days prior to trial start)
- Corneal stromal thickness below 400 μm (unless not affecting more than 50% of the corneal surface area)
- Active or suspected intraocular inflammation
- Active corneal ulceration
- Dysregulated glaucoma with IOP values > 25 mmHg despite local therapy
- Compromised eyelid mobility and/or symblepharon
- Allergy, sensitivity or intolerance to riboflavin or UV
- Contraindications to the local or systemic antibiotics and/or corticosteroids foreseen by the protocol
- Contraindications to the surgical protocol
- 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: o Oral hormonal contraception (‘pill’) o Dermal hormonal contraception o Vaginal hormonal contraception (NuvaRing® ) o Contraceptive plaster o Long-acting injectable contraceptives o Implants that release progesterone (Implanon® ) o Tubal ligation (female sterilisation) o Intrauterine devices that release hormones (hormone spiral) o Avoiding sexual activities that could lead to pregnancy
- Rheumatic diseases that require systemic treatment
- Participants unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study 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 ex-amination, or laboratory findings) that may interfere with the planned treatment, affect the participant’s compliance, or place the participant at high risk of complications related to the treatment
- Employees of the sponsor, or employees or relatives of the investigator
- Pregnant women and nursing mothers as the effects of study medication is unknown in these conditions
- Persons held in an institution by legal or official order
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.