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VOROLANIB

Clinical trials investigating VOROLANIB are studying its use in eye diseases, mainly wet age-related macular degeneration and diabetic macular edema. These trials are looking at vision benefits, safety, and how VOROLANIB compares with aflibercept in adults. All listed studies are Phase 3 and are authorised.

Table of Contents

Trial overview

The available data describe three authorised interventional studies of VOROLANIB. These studies are testing whether it can provide the same vision benefit as aflibercept, which is the comparison treatment used in all listed trials.[1][2][3]

Two trials study diabetic macular edema, and one trial studies wet age-related macular degeneration.[1][2][3] All three studies are in Phase 3, which means they are larger studies meant to compare results with standard treatment.[1][2][3]

Conditions being studied

One study, LUCIA, is in people with wet age-related macular degeneration (wAMD).[1] This is an eye disease that affects the central part of vision and can make reading and recognizing faces harder.

The other two studies, CAPRI and COMO, are in people with diabetic macular edema (DME).[2][3] DME means swelling in the macula, the part of the eye needed for sharp central vision.

Study design and phases

All listed trials are randomized and double-masked.[1][2][3] Randomized means participants are placed into study groups by chance, and double-masked means neither the participant nor the study team knows which treatment is being given during the study.

Each trial is an intravitreal study, which means the treatment is given into the eye.[1][2][3] The source data does not give more details about the visit schedule or other study procedures.

The three studies are all Phase 3 trials.[1][2][3] In this stage, researchers usually want to confirm how well a treatment works in larger groups and compare it with the current standard treatment.

What the trials measure

The main endpoint in each study is to find out whether VOROLANIB can produce the same vision benefits as aflibercept over 56 weeks.[1][2][3] An endpoint is the main result the researchers are measuring.

The brief summaries say the studies are evaluating changes in best corrected visual acuity (BCVA).[1][2][3] BCVA is the best vision a person can get with the right glasses or lenses, so it is a common way to measure vision improvement in eye studies.

Who can participate

The source data shows that the studies are for adults with either wAMD or DME, depending on the trial.[1][2][3] No further entry rules are listed in the provided data.

The planned enrollment is 400 people in LUCIA and 240 people in each of the two DME studies.[1][2][3] Enrollment means the number of participants the study plans to include.

Summary of the listed trials

  • LUCIA is a Phase 3 study in wet age-related macular degeneration with 400 planned participants.[1]
  • CAPRI is a Phase 3 study in diabetic macular edema with 240 planned participants.[2]
  • COMO is a Phase 3 study in diabetic macular edema with 240 planned participants.[3]
  • All three studies compare VOROLANIB with aflibercept and measure vision benefit over 56 weeks.[1][2][3]
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 conditions are being studied in VOROLANIB trials? The trials are studying wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Both conditions affect the retina and can reduce vision.
  • What is the main goal of these trials? The main goal is to see whether VOROLANIB can give the same vision benefits as aflibercept over 56 weeks. The studies also measure changes in best corrected visual acuity, which means the best vision a person can get with the right glasses or lenses.
  • Who can take part in these studies? The trials are for adults with wAMD or DME, depending on the study. The source data does not list more detailed entry rules.
  • What phase are the VOROLANIB trials in? All listed trials are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to compare its effects with standard care.
  • How many studies are listed for VOROLANIB? Three authorised interventional studies are listed. One study is in wAMD, and two studies are in DME.

Ongoing Clinical Trials on VOROLANIB

  • A study comparing the effectiveness of vorolanib and aflibercept in patients with diabetic macular edema

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Poland Slovakia

  • A study comparing the effectiveness of vorolanib and aflibercept in patients with diabetic macular edema

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary

  • Study Comparing EYP-1901 and Aflibercept for Patients with Wet Age-Related Macular Degeneration

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Czechia Germany Hungary Poland Slovakia

Glossary

  • Wet age-related macular degeneration (wAMD): An eye disease that affects the macula, the part of the retina needed for sharp central vision. It can cause blurred or lost central vision.
  • Diabetic Macular Edema (DME): Swelling in the macula caused by diabetes. It can make central vision blurry.
  • Retina: The light-sensitive layer at the back of the eye that helps you see.
  • Macula: The center part of the retina that gives you clear, detailed vision.
  • Best corrected visual acuity (BCVA): A measure of the best vision a person can achieve with glasses or contact lenses.
  • Aflibercept: The treatment used as the comparison drug in these studies. The trials are checking whether VOROLANIB gives similar vision results.
  • Phase 3: A later stage of clinical testing in larger groups of people. It helps compare a study treatment with standard treatment.
  • Randomized: Participants are put into study groups by chance, not by choice.
  • Double-masked: Neither the participants nor the study team know which treatment is being given, to reduce bias.
  • Interventional study: A trial where researchers give a treatment and then measure the results.
  • Intravitreal: Given into the eye.
  • Enrollment: The number of people planned for the study.

References

  1. https://clinicaltrials.eu/trial/study-comparing-eyp-1901-and-aflibercept-for-patients-with-wet-age-related-macular-degeneration/
  2. https://clinicaltrials.gov/study/2025-523938-10-00
  3. https://clinicaltrials.gov/study/2025-523937-25-00