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XELAFASLATIDE

Clinical trials investigating XELAFASLATIDE are studying whether it can slow disease progression in people with atrophic age-related macular degeneration. These studies mainly look at safety and efficacy, especially in patients with geographic atrophy. The trial data here focuses on a Phase 2 study comparing treatment with a sham injection.

Table of contents

Trial overview

The available trial data shows one interventional study of XELAFASLATIDE in atrophic age-related macular degeneration (AMD), which is a form of eye disease that can damage central vision.[1]

The study is designed to evaluate whether XELAFASLATIDE can slow the progression of disease in patients with geographic atrophy (GA) associated with AMD.[1]

Who the trial is for

This trial targets people who have atrophic AMD, with the brief summary specifically naming patients with geographic atrophy linked to AMD.[1]

The source data does not list the full inclusion or exclusion rules, so we only know the main condition being studied from the trial record.[1]

What the study is testing

The study compares XELAFASLATIDE with a sham injection, which means a fake procedure used to help show whether the real treatment has an effect.[1]

The intervention is listed as an ophthalmic solution for intravitreal use, which means it is intended for use in the eye.[1]

The trial summary says the goal is to evaluate efficacy, meaning whether the treatment helps slow the disease compared with the sham procedure.[1]

Trial phase and design

This is a Phase 2 trial, which is a study stage that usually looks more closely at whether a treatment may work while continuing to monitor safety.[1]

The study type is interventional, meaning the researchers assign a treatment and compare outcomes between groups.[1]

What researchers are measuring

The main outcome is GA lesion area assessment.[1]

This means the researchers measure the size of the geographic atrophy area in the retina to see whether the disease is progressing more slowly.[1]

Study status and size

The trial status is listed as Authorised.[1]

The planned enrollment is 324 participants, which gives the study a moderate size for a Phase 2 trial.[1]

Only one trial record was provided, so the article is based on that single study of XELAFASLATIDE.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06659445 Phase 2 Atrophic Age-related Macular Degeneration, geographic atrophy associated with AMD Authorised 324

FAQ

  • What is being studied in the XELAFASLATIDE trial? The trial is studying whether XELAFASLATIDE can slow the progression of atrophic age-related macular degeneration. It compares the study treatment with a sham injection, which is a fake procedure used for comparison.
  • Who can take part in the study? The trial is for patients with atrophic age-related macular degeneration, also called geographic atrophy associated with AMD. The source data does not list more detailed entry rules.
  • What phase is the XELAFASLATIDE trial? This is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment may work and continue to monitor safety.
  • What outcome is the study measuring? The main outcome is GA lesion area assessment. This means the researchers measure the size of the geographic atrophy area to see if it changes over time.
  • How many people are planned for the study? The trial plans to enroll 324 participants. This helps researchers compare results between the treatment and sham groups.

Ongoing Clinical Trials on XELAFASLATIDE

  • Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Greece Hungary Italy +3

Glossary

  • Atrophic age-related macular degeneration (AMD): An eye disease that affects the macula, the part of the retina needed for clear central vision. The atrophic form involves gradual loss of retinal tissue.
  • Geographic atrophy (GA): A later stage of atrophic AMD where areas of the retina become damaged and thin. Trials may measure the size of these areas to track disease progression.
  • Phase 2: A stage of clinical research that studies whether a treatment may work and continues to check safety in a larger group of people.
  • Interventional study: A trial in which researchers give a treatment or procedure and compare results between groups.
  • Sham injection: A fake or inactive procedure used in a trial to compare against the real treatment. It helps show whether the study treatment makes a difference.
  • Intravitreal use: Treatment given into the eye, specifically into the vitreous, the jelly-like fluid inside the eye.
  • Primary outcome: The main result the researchers plan to measure in the trial.
  • GA lesion area assessment: A measurement of the size of the geographic atrophy area in the eye. It helps researchers see whether the disease is getting worse more slowly.
  • Enrollment: The number of people planned to join the study.
  • Authorised: The study has been approved to start or continue according to the source data.

References