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VOROLANIB

Clinical trials investigating VOROLANIB are studying eye diseases that affect vision, especially wet age-related macular degeneration and diabetic macular edema. These studies are looking at how well the treatment works compared with aflibercept and whether it can give similar vision benefits over 56 weeks. The trials include adults in Phase 3 studies.

Table of contents

Clinical trials overview

The listed studies of VOROLANIB are all Phase 3 interventional trials, which means they test a treatment in people and compare results in a larger group.[1][2][3] Each trial is authorised and looks at whether VOROLANIB can give the same vision benefit as aflibercept.[1][2][3]

The three listed studies are called LUCIA, CAPRI, and COMO.[1][2][3] They all use the same general goal: to compare vision change over 56 weeks.[1][2][3]

Conditions studied

One trial studies wet age-related macular degeneration (wAMD), a condition that can harm the part of the eye needed for sharp central vision.[1] The other two trials study diabetic macular edema (DME), which is swelling in the macula caused by diabetes and can blur vision.[2][3]

These conditions are important because they can reduce the ability to read, drive, or recognize faces clearly.[1][2][3] The studies focus on whether treatment can improve or preserve vision in these eye diseases.[1][2][3]

How the studies are designed

All three trials are described as randomized and double-masked.[1][2][3] Randomized means people are assigned by chance to a treatment group, and double-masked means neither the participant nor the study staff knows which treatment is given.[1][2][3]

The comparison treatment in each study is aflibercept, listed as Eylea in the trial data.[1][2][3] This design helps researchers see whether VOROLANIB performs as well as the current comparison treatment.[1][2][3]

The trials use intravitreal treatment, which means the study drug is given into the eye.[1][2][3] This is relevant because all studies are about eye disease and vision outcomes.[1][2][3]

Main outcomes measured

The main outcome in every listed trial is whether VOROLANIB can produce the same vision benefits as aflibercept over 56 weeks.[1][2][3] A primary endpoint is the main result the study plans to measure first.[1][2][3]

The trials also measure best corrected visual acuity (BCVA), which means how well a person can see with the best possible glasses or contact lenses.[1][2][3] In simple terms, this tells researchers how much the treatment helps a person see more clearly.[1][2][3]

In the trial summaries, the goal is described as evaluating the efficacy of VOROLANIB inserts compared with aflibercept treatment.[1][2][3] Efficacy means how well a treatment works in a study setting.[1][2][3]

Who can participate

The trial data do not give full eligibility rules such as age limits, test results, or previous treatments.[1][2][3] Based on the listed conditions, participants are people with either wet age-related macular degeneration or diabetic macular edema, depending on the study.[1][2][3]

The studies are large enough to include 400 people in one trial and 240 people in each of the two diabetic macular edema trials.[1][2][3] This size helps researchers compare results across groups more reliably.[1][2][3]

Summary of the listed trials

The table below brings together the most important details from the three listed studies.[1][2][3]

Trial ID Title Phase Condition Status Enrollment Main endpoint
NCT06683742 LUCIA Phase 3 Wet age-related macular degeneration (wAMD) Authorised 400 Same vision benefits as aflibercept over 56 weeks
2025-523938-10-00 CAPRI Phase 3 Diabetic Macular Edema (DME) Authorised 240 Same vision benefits as aflibercept over 56 weeks
2025-523937-25-00 COMO Phase 3 Diabetic Macular Edema (DME) Authorised 240 Same vision benefits as aflibercept over 56 weeks
Trial ID Phase Condition studied Status Enrollment
NCT06683742 Phase 3 Wet age-related macular degeneration (wAMD) Authorised 400
2025-523938-10-00 Phase 3 Diabetic Macular Edema (DME) Authorised 240
2025-523937-25-00 Phase 3 Diabetic Macular Edema (DME) Authorised 240

FAQ

  • What is being studied in the VOROLANIB trials? The trials are studying whether VOROLANIB can provide the same vision benefits as aflibercept. They focus on changes in best corrected visual acuity, which means the clearest vision a person can get with glasses or contact lenses.
  • Which eye conditions are included? The trials include wet age-related macular degeneration and diabetic macular edema. Both conditions can damage the retina and affect central vision.
  • What phase are these trials? All listed studies are Phase 3 trials. Phase 3 studies compare treatments in larger groups of people to see how well they work.
  • Who may take part? Adults with wet age-related macular degeneration or diabetic macular edema may be included, depending on the specific study. The trials are randomized and double-masked, meaning participants and study staff do not know which treatment is given.
  • What result are the trials trying to measure? The main result is whether VOROLANIB can match aflibercept in vision benefits over 56 weeks. The studies measure vision change, especially best corrected visual acuity.

Sperimentazioni cliniche in corso su VOROLANIB

  • Studio per confrontare l’efficacia di vorolanib rispetto ad aflibercept in pazienti con edema maculare diabetico

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Germania Polonia Slovacchia

  • Studio sull’efficacia di EYP-1901 rispetto ad aflibercept in pazienti con edema maculare diabetico

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Cechia Germania Ungheria

  • Studio clinico su EYP-1901 e aflibercept per pazienti con degenerazione maculare senile umida

    Arruolamento concluso

    1 1 1 1
    Farmaci in studio:
    Cechia Germania Ungheria Polonia Slovacchia

Glossario

  • Wet age-related macular degeneration (wAMD): An eye disease that affects the macula, the part of the retina needed for sharp central vision. The 'wet' form can cause fluid or bleeding and may lead to vision loss.
  • Diabetic macular edema (DME): Swelling in the macula caused by diabetes. It can blur central vision and make reading or recognizing faces harder.
  • Macula: The small central part of the retina that helps you see fine details straight ahead.
  • Retina: The light-sensitive layer at the back of the eye that sends visual signals to the brain.
  • Best corrected visual acuity (BCVA): A measure of how well a person can see with the best possible glasses or contact lenses. It is often used in eye studies to track vision changes.
  • Aflibercept: The comparison treatment used in these studies. It is the standard treatment the trial is testing against.
  • Randomized: Participants are assigned by chance to one treatment or another. This helps make the results fair.
  • Double-masked: Neither the participant nor the study staff knows which treatment is being given. This helps reduce bias.
  • Phase 3: A late stage of clinical testing in larger groups of people. It checks how well a treatment works and continues to monitor safety and benefit.
  • Primary endpoint: The main result the study is designed to measure. In these trials, it is whether VOROLANIB gives the same vision benefit as the comparison treatment over 56 weeks.

Riferimenti

  1. https://studi-clinici.it/studio/studio-clinico-su-eyp-1901-e-aflibercept-per-pazienti-con-degenerazione-maculare-senile-umida/
  2. https://clinicaltrials.gov/study/2025-523938-10-00
  3. https://clinicaltrials.gov/study/2025-523937-25-00