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Antisense Oligonucleotide Eye Drops against IRS-1 to Optimize Pretransplant Lymphangio-regression Prior to High-Risk Keratoplasty (Olisens-Precon)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522099-10-00
Enrollment
10
Registered
2026-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathologically prevascularized corneas due to herpetic keratopathy prior to “high-risk” corneal transplantation (keratoplasty)

Brief summary

Relative change in the corneal area covered by CoNV measured by digital standardized slit-lamp images.

Detailed description

Best corrected visual acuity measured by ETDRS charts (transformed to LogMAR (Logarithm of the Minimum Angle of Resolution)), Best corrected glare visual acuity measured by ETDRS charts (transformed to LogMAR (Loga-rithm of the Minimum Angle of Resolution)), Vision related Quality of Life assessed by overall score of NEI-VFQ25, Intraocular Pressure measured by Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining according to 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 participants, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry (vessel thickness, vessel length, vessel regression, vessel recurrence), Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Assessment Survey (OPAS), Safety: Retinal adverse events (Optical Coherence Tomography), Change in need for subsequent transplantation (as assessed by PI), Compliance of CXL postoperative medication recorded via daily patient self-documentation

Interventions

DRUGFloxal EDO 3 mg/ml Augentropfen
DRUGDexa EDO® 1
DRUG3 mg/ml Augentropfen
DRUGPlacebo eye drops are nearly identical to the Olisens eye drops
DRUGexcept for the active substance. For details see IMPD_Placebo

Sponsors

University Of Cologne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Relative change in the corneal area covered by CoNV measured by digital standardized slit-lamp images.

Secondary

MeasureTime frame
Best corrected visual acuity measured by ETDRS charts (transformed to LogMAR (Logarithm of the Minimum Angle of Resolution)), Best corrected glare visual acuity measured by ETDRS charts (transformed to LogMAR (Loga-rithm of the Minimum Angle of Resolution)), Vision related Quality of Life assessed by overall score of NEI-VFQ25, Intraocular Pressure measured by Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining according to 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 participants, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry (vessel thickness, vessel length, vessel regression, vessel recurrence), Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Assessment Survey (OPAS), Safety: Retinal adverse events (Op

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026