AGANIRSEN for Herpetic keratitis | Corneal neovascularisation

Inclusion criteria

• {"criterion_text":"- Pathologically prevascularized cornea due to herpetic keratopathy (diagnosis either through virology or clinical findings) with need for corneal transplantation"}
• {"criterion_text":"- Written informed consent by participant and/or witness prior to any study-related procedures"}
• {"criterion_text":"- Adult male and female participants ≥ 18 years old"}
• {"criterion_text":"- ≥ 2 corneal quadrants covered by pathological corneal neovascularization due to herpetic keratitis"}
• {"criterion_text":"- Absence of other clinical contraindications to any part or product of the treatment plan"}
• {"criterion_text":"- A cooperative attitude to follow up the study procedures"}
• {"criterion_text":"- In case of bilateral disease only one eye will be included (the responsible investigator will decide based on which eye is more affected)"}
• {"criterion_text":"- High-risk eye on the waitlist for a corneal transplantation"}

Exclusion criteria

• {"criterion_text":"- < 2 corneal quadrants covered by pathological neovascularization"}
• {"criterion_text":"- Rheumatic diseases that require systemic treatment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit"}
• {"criterion_text":"- Known abuse of alcohol, drugs, or medicinal products"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Employees of the sponsor, or employees or relatives of the investigator"}
• {"criterion_text":"- Pregnant women and nursing mothers as the effects of study medication is unknown in these conditions"}
• {"criterion_text":"- Persons held in an institution by legal or official order"}
• {"criterion_text":"- Use of autologous or allogenous serum eye drops during study period (have to be stopped 14 days prior to trial start)"}
• {"criterion_text":"- Corneal stromal thickness below 400 µm (unless not affecting more than 50% of the corneal surface area)"}
• {"criterion_text":"- Active or suspected intraocular inflammation"}
• {"criterion_text":"- Active corneal ulceration"}
• {"criterion_text":"- Dysregulated glaucoma with IOP values > 25 mmHg despite local therapy"}
• {"criterion_text":"- Compromised eyelid mobility and/or symblepharon"}
• {"criterion_text":"- Allergy, sensitivity or intolerance to riboflavin or UV"}
• {"criterion_text":"- Contraindications to the local or systemic antibiotics and/or corticosteroids foreseen by the protocol"}
• {"criterion_text":"- Contraindications to the surgical protocol"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Relative change in the corneal area covered by CoNV measured by digital standardized slit-lamp images.","definition_or_measurement_approach":"Measured by digital standardized slit-lamp images (relative change in corneal area covered by corneal neovascularization, CoNV)."}

Secondary endpoints

• {"endpoint_text":"- Best corrected visual acuity measured by ETDRS charts (transformed to LogMAR (Logarithm of the Minimum Angle of Resolution))","definition_or_measurement_approach":"Measured by ETDRS charts and transformed to LogMAR."}
• {"endpoint_text":"- Best corrected glare visual acuity measured by ETDRS charts (transformed to LogMAR (Loga-rithm of the Minimum Angle of Resolution))","definition_or_measurement_approach":"Measured by ETDRS charts under glare conditions and transformed to LogMAR."}
• {"endpoint_text":"- Vision related Quality of Life assessed by overall score of NEI-VFQ25","definition_or_measurement_approach":"Assessed by overall NEI-VFQ25 questionnaire score."}
• {"endpoint_text":"- Intraocular Pressure measured by Goldmann applanation tonometry, reported as mmHg","definition_or_measurement_approach":"Measured by Goldmann applanation tonometry; reported in mmHg."}
• {"endpoint_text":"- Ocular Surface Staining according to Oxford Grading Scale (Grades 0-5)","definition_or_measurement_approach":"Assessed using the Oxford Grading Scale (grades 0-5)."}
• {"endpoint_text":"- Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participants","definition_or_measurement_approach":"Measured using a Cochet-Bonnet esthesiometer; reported as length of nylon monofilament at detection."}
• {"endpoint_text":"- Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2)","definition_or_measurement_approach":"Measured by Pentacam Scheimpflug tomography or Casia-2 AS-OCT."}
• {"endpoint_text":"- Vessel Morphometry (vessel thickness, vessel length, vessel regression, vessel recurrence)","definition_or_measurement_approach":"Analysis of vessel morphometry parameters (thickness, length, regression, recurrence) from digital images."}
• {"endpoint_text":"- Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Assessment Survey (OPAS)","definition_or_measurement_approach":"Assessed by OPAS overall score."}
• {"endpoint_text":"- Safety: Retinal adverse events (Optical Coherence Tomography)","definition_or_measurement_approach":"Safety assessed by retinal adverse events detected with Optical Coherence Tomography (OCT)."}
• {"endpoint_text":"- Change in need for subsequent transplantation (as assessed by PI)","definition_or_measurement_approach":"Assessed by the principal investigator regarding need for subsequent corneal transplantation."}
• {"endpoint_text":"- Compliance of CXL postoperative medication recorded via daily patient self-documentation","definition_or_measurement_approach":"Recorded by daily patient self-documentation (diary) of postoperative medications."}

Germany

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

19

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

University Of Cologne

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Nitto Denko Avecia Inc.","duties_or_roles":"Manufacture and release of Active Pharmaceutical Ingredient","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Analysis of CoNV area and vessel morphometry through digital standardized slit-lamp images","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"France","full_name":"Laboratoires Kol","duties_or_roles":"Marketing authorisation holder IMP","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Laboratoire Unither","duties_or_roles":"Manufacture of finished product, primary and secondary packaging, control, stability studies and release","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Clinical Packaging and Batch Certification","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"sponsorDuties codes: 1, 12, 5, 6, 8","organisation_type":"Hospital/Clinic/Other health care facility"}