#1 Clinical Trials Search in Europe

Timbetasin Acetate

A new clinical trial is investigating the potential of Timbetasin Acetate, a synthetic version of a naturally occurring peptide, in treating Neurotrophic Keratopathy (NK). This eye condition, characterized by decreased corneal sensitivity and persistent epithelial defects, has been challenging to treat effectively. The study aims to evaluate the safety and efficacy of RGN-259, a 0.1% Timbetasin Acetate ophthalmic solution, compared to a placebo in patients with NK.

Table of Contents

What is Timbetasin Acetate?

Timbetasin acetate is a promising new medication being studied for the treatment of a serious eye condition called neurotrophic keratopathy. It is also known by its code name RGN-259[1]. This medication comes in the form of eye drops containing 0.1% timbetasin acetate solution[1].

Interestingly, timbetasin acetate is a synthetic version of a naturally occurring substance in our bodies called Thymosin beta 4 (Tβ4). This substance is a small protein (peptide) made up of 43 amino acids[1]. By mimicking this natural protein, timbetasin acetate aims to help heal and protect the surface of the eye.

What is Neurotrophic Keratopathy?

Neurotrophic keratopathy is a rare but serious eye disease that affects the cornea, which is the clear, front part of your eye[1]. In this condition, nerve damage leads to a loss of sensation in the cornea. This loss of sensation can result in poor healing of the eye surface, leading to persistent sores or defects that don’t heal properly.

One of the main signs of neurotrophic keratopathy is a persistent epithelial defect (PED). This is essentially a sore on the surface of the eye that doesn’t heal as it should[1]. These defects can be very uncomfortable and, if left untreated, can lead to serious complications, including vision loss.

How Timbetasin Acetate Works

While the exact mechanism is still being studied, timbetasin acetate is believed to work by promoting healing of the eye surface. It may help to:

  • Encourage the growth and migration of cells that make up the surface of the eye
  • Reduce inflammation
  • Promote the formation of new blood vessels, which can aid in healing
  • Protect the eye cells from further damage

Clinical Trial Details

Timbetasin acetate is currently being studied in a Phase 3 clinical trial called SEER-3[1]. This is an advanced stage of research that aims to confirm the effectiveness and safety of the medication. Here are some key details about the trial:

  • It’s a randomized, double-masked, placebo-controlled study. This means that participants are randomly assigned to receive either the real medication or a placebo (a similar eye drop without the active ingredient), and neither the participants nor the researchers know who is receiving which[1].
  • The study is taking place at multiple medical centers, which helps ensure that the results are reliable and applicable to a wide range of patients[1].
  • The main goal is to compare how well timbetasin acetate works compared to a placebo in treating neurotrophic keratopathy[1].

Eligibility Criteria

The study has specific criteria for who can participate. Some key points include:

  • Participants must be at least 18 years old[1].
  • They must have a persistent epithelial defect (PED) in one or both eyes that hasn’t healed after at least a week of standard treatments[1].
  • The eye condition must be classified as stage 2 or 3 neurotrophic keratopathy, based on a system called the Mackie Classification[1].
  • Participants must have decreased sensitivity in the affected area of the eye[1].

There are also several conditions that would prevent someone from participating, such as certain other eye conditions, recent eye surgeries, or use of specific medications[1].

Potential Benefits

While the full results of the study are not yet known, researchers hope that timbetasin acetate may offer several benefits for people with neurotrophic keratopathy:

  • Healing of persistent epithelial defects (PEDs)[1]
  • Improvement in corneal sensitivity[1]
  • Better visual acuity (clearer vision)[1]
  • Reduction in symptoms such as eye discomfort, sensitivity to light, feeling of something in the eye, burning, and dryness[1]

Safety Considerations

As with any new medication, safety is a top priority in this study. The researchers are carefully monitoring for any side effects or adverse reactions[1]. They’re checking things like:

  • Changes in eye pressure
  • Any changes in the back of the eye (observed through dilated eye exams)
  • Any other unexpected effects

It’s important to note that while timbetasin acetate shows promise, it is still considered an experimental treatment. More research is needed to fully understand its effectiveness and safety profile. If you have neurotrophic keratopathy and are interested in this treatment, it’s crucial to discuss it with your eye doctor to understand if it might be appropriate for you and to learn about any available clinical trials.

Aspect Details
Study Drug RGN-259 (0.1% Timbetasin Acetate ophthalmic solution)
Condition Neurotrophic Keratopathy (NK)
Study Design Phase 3, multi-center, randomized, double-masked, placebo-controlled
Primary Objectives 1. Assess complete healing of persistent epithelial defect at Day 29
2. Evaluate safety through adverse events and eye health changes
Key Inclusion Criteria 1. Age ≥18 years
2. Stage 2 or 3 NK
3. Persistent epithelial defect ≥1 mm
4. Decreased corneal sensitivity
Key Exclusion Criteria 1. Recent eye surgeries
2. Certain medical conditions
3. Use of specific medications
Treatment Duration 4 weeks
Follow-up Multiple visits over the study period

FAQ

  • What is Neurotrophic Keratopathy (NK)? Neurotrophic Keratopathy is an eye condition characterized by decreased corneal sensitivity and persistent epithelial defects on the cornea. It can lead to vision problems and discomfort if left untreated.
  • What is Timbetasin Acetate? Timbetasin Acetate is a synthetic copy of a naturally occurring 43-amino acid peptide called Thymosin beta 4 (Tβ4). In this trial, it's being tested as an eye drop solution for treating Neurotrophic Keratopathy.
  • How is the clinical trial designed? The trial is a Phase 3, multi-center, randomized, double-masked, placebo-controlled study. Participants will receive either the RGN-259 eye drops or a placebo, and their progress will be monitored over several visits.
  • What are the main goals of this clinical trial? The primary objectives are to assess the percentage of patients achieving complete healing of their persistent epithelial defect after 29 days of treatment, and to evaluate the safety of the medication through monitoring adverse events and changes in eye health.
  • Who can participate in this clinical trial? Participants must be at least 18 years old, have stage 2 or 3 neurotrophic keratopathy with a persistent epithelial defect, and meet specific criteria for corneal sensitivity and visual acuity. There are also several exclusion criteria, such as recent eye surgeries or certain medical conditions.

Ongoing Clinical Trials on Timbetasin Acetate

  • Study on the Safety and Effectiveness of Timbetasin Acetate Eye Drops for Patients with Neurotrophic Keratopathy

    Recruiting

    1 1
    Investigated drugs:
    Italy Poland Spain

  • Study on the Safety and Effectiveness of RGN-259 Eye Drops for Patients with Neurotrophic Keratopathy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Poland Spain

Glossary

  • Neurotrophic Keratopathy (NK): An eye condition characterized by decreased corneal sensitivity and persistent epithelial defects on the cornea's surface.
  • Timbetasin Acetate: A synthetic version of Thymosin beta 4, a naturally occurring peptide being tested as a treatment for NK.
  • RGN-259: The code name for the 0.1% Timbetasin Acetate ophthalmic solution being studied in this clinical trial.
  • Persistent Epithelial Defect (PED): A corneal epithelial defect that has not healed after at least one week of conventional treatment.
  • Corneal sensitivity: The ability of the cornea to respond to touch or other stimuli, which is reduced in NK patients.
  • BCVA (Best Corrected Visual Acuity): A measure of the best vision a person can achieve with corrective lenses, used as part of the eligibility criteria for this study.
  • Cochet-Bonnet aesthesiometer: An instrument used to measure corneal sensitivity.
  • Fluorescein staining: A technique used to visualize and measure corneal defects by applying a fluorescent dye to the eye.
  • Central Reading Center: A facility that independently analyzes and interprets clinical trial data to ensure consistency and reduce bias.
  • Mackie Classification: A system used to categorize the severity of neurotrophic keratopathy into stages.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-rgn-259-eye-drops-for-patients-with-neurotrophic-keratopathy/