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AGANIRSEN

Clinical trials are investigating AGANIRSEN in people with corneal neovascularization, a condition where new blood vessels grow into the clear front part of the eye. These studies aim to evaluate whether the treatment can reduce this vessel growth and how well it works in specific eye diseases, including herpetic keratopathy and aniridia-associated keratopathy.

Table of contents

Clinical trial overview

AGANIRSEN is being studied in two authorised Phase 2 interventional trials.[1][2] Both studies focus on corneal neovascularization, which means new blood vessels growing into the cornea, the clear front part of the eye.[1][2]

These trials are small and are designed to see whether AGANIRSEN can reduce the area of the cornea covered by these blood vessels.[1][2] The studies are not the same disease setting: one is in herpetic keratopathy before corneal transplantation, and the other is in aniridia-associated keratopathy.[1][2]

Trial 1: Herpetic keratopathy before high-risk keratoplasty

The first trial, NCT 2025-522099-10-00, is called Olisens-Precon and is authorised.[1] It studies people with pathologically prevascularized corneas due to herpetic keratopathy before high-risk keratoplasty, which means corneal transplantation in an eye with a higher chance of problems.[1]

This study is interventional, so researchers are giving study treatments and then measuring the results.[1] The trial plans to enroll 10 participants and is in Phase 2.[1]

The brief summary says the study is evaluating the efficacy of antisense oligonucleotide eye drops against IRS-1, called OLISENS, for pathological neovascularization due to herpetic keratopathy, together with physical angioregressive treatment using corneal crosslinking.[1] In simple words, the researchers want to know if this treatment approach can reduce unwanted blood vessel growth in the cornea before transplant surgery.[1]

The trial compares OLISENS with placebo eye drops, and also lists Floxal EDO and Dexa EDO as study drugs in the intervention section.[1] The main outcome is the relative change in the corneal area covered by CoNV, measured with digital standardized slit-lamp images.[1]

Trial 2: Aniridia-associated keratopathy

The second trial, NCT 2025-522609-39-00, is called OLISENS-ANIRIDIA and is also authorised.[2] It studies corneal neovascularization in aniridia-associated keratopathy, which is corneal disease linked to aniridia.[2]

This is also a Phase 2 interventional study, and it plans to enroll 20 participants.[2] The trial uses OLISENS eye drops and aims to show whether they can halt or reduce corneal neovascularization in affected eyes.[2]

The primary outcome is the relative change of the corneal area covered by CoNV, assessed by digital standardized slit-lamp images and an independent reading center.[2] This means the study uses eye pictures and a separate reviewer group to measure the blood vessel area in a careful and standardized way.[2]

What the trials measure

Both trials use the same main idea for measuring success: they look at how much of the cornea is covered by new blood vessels before and after treatment.[1][2] This is called the primary outcome, which is the most important result in the study.[1][2]

In the first trial, the result is measured with digital standardized slit-lamp images.[1] In the second trial, the images are also reviewed by an independent reading center, which adds another level of careful assessment.[2]

Who the trials are for

These studies are not for general eye disease; they are for specific groups with corneal neovascularization.[1][2] One group has corneal vessel growth caused by herpetic keratopathy before possible transplant surgery, and the other has corneal vessel growth in aniridia-associated keratopathy.[1][2]

The trials are small, with planned enrollment of 10 and 20 people, so they are focused studies rather than large population trials.[1][2] The source data do not provide more detailed inclusion or exclusion rules, so only these target populations can be confirmed.[1][2]

Important terms explained

Interventional study means the researchers give a treatment and then watch what happens.[1][2] Authorised means the study has been approved to move forward.[1][2]

Antisense oligonucleotide is a type of study treatment named in the trial description, but the trial records here mainly show that it is being tested as eye drops rather than explaining how it works.[1][2] Corneal crosslinking is a physical treatment mentioned in the first study as part of the treatment approach.[1]

Slit-lamp images are special eye photos used to look closely at the cornea and measure the area affected by blood vessels.[1][2] Enrollment is the number of participants planned for a trial.[1][2]

Trial ID Phase Condition studied Status Enrollment
2025-522099-10-00 Phase 2 Pathologically prevascularized corneas due to herpetic keratopathy before high-risk keratoplasty Authorised 10
2025-522609-39-00 Phase 2 Corneal neovascularization in aniridia-associated keratopathy Authorised 20

FAQ

  • What are the AGANIRSEN clinical trials studying? The trials are studying whether AGANIRSEN eye drops can reduce corneal neovascularization, which means unwanted new blood vessels in the cornea. One study looks at people with herpetic keratopathy before high-risk corneal transplantation, and the other looks at people with aniridia-associated keratopathy.
  • Who can take part in these trials? The studies are for people with corneal neovascularization linked to specific eye conditions. One trial includes patients with pathologically prevascularized corneas due to herpetic keratopathy, and the other includes patients with corneal neovascularization in aniridia-associated keratopathy.
  • What phase are the AGANIRSEN trials in? Both trials are Phase 2 studies. Phase 2 trials usually look at early signs of efficacy, meaning whether the treatment seems to work, while also collecting more information about its performance in the study group.
  • What outcomes are being measured? The main outcome in both trials is the change in the corneal area covered by corneal neovascularization. This is measured using standardized digital slit-lamp images, and one study also uses an independent reading center to assess the images.
  • How many people are planned for these studies? One trial plans to include 10 participants, and the other plans to include 20 participants. These are small studies, which is common in early-phase research.

Ongoing Clinical Trials on AGANIRSEN

  • Testing Aganirsen Eye Drops in Patients with Corneal Blood Vessel Growth from Herpes Eye Disease Before Corneal Transplant Surgery

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Germany

  • A Study of Aganirsen Eye Drops for Patients with Corneal Blood Vessel Growth in Aniridia-Associated Keratopathy

    Not yet recruiting

    2 1 1 1
    Investigated drugs:
    Germany

Glossary

  • Cornea: The clear front surface of the eye that helps focus light.
  • Corneal neovascularization (CoNV): Growth of new blood vessels into the cornea, which is normally clear and has no blood vessels.
  • Keratopathy: A disease of the cornea. In these trials, it refers to corneal disease linked to herpes or aniridia.
  • Herpetic keratopathy: Corneal disease caused by herpes infection.
  • Aniridia-associated keratopathy (AAK): Corneal disease linked to aniridia, a condition where part or all of the iris is missing.
  • High-risk keratoplasty: Corneal transplantation with a higher chance of failure, often because the eye has other problems such as blood vessel growth in the cornea.
  • Phase 2: A study stage that checks early effectiveness and continues safety monitoring in a small group of patients.
  • Enrollment: The number of participants planned for a trial.
  • Primary outcome: The main result the researchers want to measure.
  • Slit-lamp image: A detailed eye photograph taken with a special microscope-like device used by eye doctors.
  • Independent reading center: A separate group that reviews study images to help make the assessment more objective.

References

  1. https://clinicaltrials.gov/study/2025-522099-10-00
  2. https://clinicaltrials.gov/study/2025-522609-39-00