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

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What is this study about?

This study examines a condition where the cornea, which is the clear front surface of the eye, has developed abnormal blood vessels and lymphatic vessels due to herpetic keratopathy, which is damage to the cornea caused by herpes virus infection. When the cornea becomes damaged by herpes infection, new blood vessels can grow into it where they normally should not be present, making the cornea less clear and affecting vision. People with this condition may need a corneal transplant, which is a surgical procedure to replace the damaged cornea with healthy donor tissue, but the presence of these abnormal vessels increases the risk that the transplant might not work well. The study will use several treatments including eye drops called Olisens that contain aganirsen, which is a substance designed to reduce the growth of these abnormal vessels. Some participants will receive placebo eye drops instead. Additionally, all participants will receive standard eye drops containing ofloxacin, which is an antibiotic to prevent infection, and dexamethasone sodium phosphate, which reduces inflammation. The study will also use a procedure called corneal crosslinking, which involves applying a special solution to the cornea and then exposing it to ultraviolet light to strengthen the cornea and help reduce the abnormal blood vessels.

The purpose of this study is to find out whether the antisense oligonucleotide eye drops work effectively in treating the abnormal blood vessels in the cornea when used together with the corneal crosslinking procedure. During the study, participants will receive either the active eye drops or placebo eye drops along with the other standard medications and will undergo the crosslinking procedure. The study will measure changes in the area of the cornea covered by abnormal blood vessels by taking standardized photographs of the eye using a special microscope called a slit lamp. The treatment period will last for several weeks, and participants will be followed for additional time to see how well the treatment works.

Throughout the study, various measurements will be taken to assess how well participants can see, including tests of visual sharpness both in normal conditions and with glare, which is bright light that can make seeing more difficult. The study will also evaluate how the condition and treatment affect quality of life related to vision and any eye pain experienced by participants. Other measurements will include eye pressure, the health of the eye surface, how well the cornea can sense touch, the thickness of the cornea, and detailed measurements of the blood vessels including their thickness and length. Safety will be monitored by examining the retina, which is the light-sensitive tissue at the back of the eye, and by tracking whether participants still need a corneal transplant after treatment.

1 Initial treatment with antibiotic eye drops

Your affected eye will receive treatment with Floxal EDO eye drops containing ofloxacin at a concentration of 3 mg/ml. Ofloxacin is an antibiotic that helps prevent infection.

These eye drops are specifically designed for use in the eye and come in a liquid form.

2 Treatment with anti-inflammatory eye drops

Your affected eye will receive treatment with Dexa EDO eye drops containing dexamethasone sodium phosphate at a concentration of 1.3 mg/ml. Dexamethasone is a medication that reduces inflammation and swelling.

These eye drops are specifically designed for use in the eye and come in a liquid form.

3 Treatment with study medication or placebo

Your affected eye will receive either Olisens eye drops or placebo eye drops. Olisens contains aganirsen at a concentration of 0.86 mg/ml, which is designed to reduce abnormal blood vessel growth in the cornea. The placebo eye drops look nearly identical but do not contain the active substance.

The treatment assigned to your eye will be determined randomly, and neither you nor the study staff will know which treatment your eye receives during the study.

These eye drops are specifically designed for use in the eye and come in single-dose containers.

4 Corneal crosslinking procedure

Your affected eye will undergo a procedure called corneal crosslinking. This is a physical treatment method that helps reduce abnormal blood vessels in the cornea.

The cornea is the clear, front surface of your eye. This procedure is performed in combination with the eye drop treatments.

5 Follow-up medication after corneal crosslinking

After the corneal crosslinking procedure, your eye will require specific medications as prescribed by the study physician.

Your adherence to this medication schedule will be recorded through daily self-documentation that you will complete.

6 Regular monitoring visits

Your eye will be examined at scheduled visits to measure various aspects of your eye health and vision.

These examinations will include measurements of the area covered by abnormal blood vessels in your cornea using standardized photographs taken with a specialized lamp.

Your visual acuity (sharpness of vision) will be tested using eye charts, both under normal conditions and with glare. The results will be recorded using a standardized scale called LogMAR.

Your eye will be examined for any staining on the surface using a grading system that ranges from 0 to 5.

The sensitivity of your cornea will be tested using a special instrument that gently touches the surface of your eye with a thin filament.

The thickness of your cornea will be measured using specialized imaging equipment.

The characteristics of blood vessels in your cornea, including their thickness, length, and any changes over time, will be assessed.

The pressure inside your eye will be measured using a standard method called Goldmann applanation tonometry, with results recorded in millimeters of mercury.

Images of your retina (the light-sensitive layer at the back of your eye) will be taken using Optical Coherence Tomography to monitor for any adverse effects.

7 Quality of life assessments

Your vision-related quality of life will be assessed using a questionnaire called NEI-VFQ25. This questionnaire asks about how your vision affects your daily activities.

Your experience of eye pain will be assessed using the Ocular Pain Assessment Survey, which evaluates various aspects of discomfort in your eye.

8 Assessment of transplantation need

The study physician will assess whether there is any change in the need for your planned corneal transplantation based on the condition of your eye following treatment.

Who Can Join the Study?

  • You must have a cornea (the clear front surface of the eye) with abnormal blood vessels growing into it caused by a herpes virus infection of the eye, confirmed either by laboratory tests or by your doctor’s examination
  • You must need a corneal transplantation (a surgical procedure to replace damaged cornea tissue with healthy donor tissue)
  • You must provide written agreement to participate in the study before any study procedures begin, and if needed, have a witness sign as well
  • You must be an adult, at least 18 years old or older
  • You must have abnormal blood vessels covering at least half of your cornea (at least 2 out of 4 sections of the cornea must be affected)
  • You must not have any other medical reasons that would prevent you from receiving any part of the planned treatment
  • You must be willing and able to follow the study schedule and attend all required appointments
  • If both of your eyes have the condition, only one eye will be included in the study, and your doctor will choose which eye based on which one is more severely affected
  • Your eye must be considered high-risk (meaning there is a higher chance of transplant rejection due to the blood vessels) and you must be on the waiting list for a corneal transplant

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial in the available information.

Where you can join this trial?

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Site Name City Country Status
Uxaykeijnp Hjsrncek Cdspcww Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
30.11.2025

Trial locations

Investigated drugs:

Olisens is an eye drop medication that contains an antisense oligonucleotide designed to work against a protein called IRS-1. This medication is being tested to reduce abnormal blood vessel growth in the eye that can occur after herpes infection damages the cornea. The eye drops are used to help prepare the eye before a cornea transplant by reducing these unwanted blood vessels, which may improve the chances of a successful transplant.

Corneal crosslinking is a physical treatment procedure used on the cornea, which is the clear front surface of the eye. This procedure uses special light and a solution to strengthen the cornea and help reduce abnormal blood vessel growth. In this trial, it is being used together with the Olisens eye drops to prepare patients for cornea transplant surgery.

Herpetic Keratopathy – Herpetic keratopathy is a viral infection of the cornea caused by the herpes simplex virus. The infection damages the clear front surface of the eye, leading to inflammation and tissue breakdown. Over time, repeated episodes of infection can cause scarring of the cornea. As the disease progresses, abnormal blood vessels may grow into the normally clear cornea, a condition called corneal neovascularization. This growth of new blood vessels makes the cornea cloudy and can significantly impair vision. The pathological prevascularization that results creates complications for potential corneal transplantation procedures.

Trial ID:
2025-522099-10-00
Protocol code:
Uni-Koeln-5379
Trial Phase:
Therapeutic exploratory (Phase II)

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