In short
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.
Key points
- Clinical trials investigating VOROLANIB are focused on eye diseases that can affect vision. The listed studies include wet age-related macular degeneration and diabetic macular edema. All three trials are Phase 3, randomized, double-masked, and authorised. They compare VOROLANIB with aflibercept and look mainly at vision benefit over 56 weeks. The studies include adults with wAMD or DME, depending on the trial.
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.
Two trials study diabetic macular edema, and one trial studies wet age-related macular degeneration. All three studies are in Phase 3, which means they are larger studies meant to compare results with standard treatment.
Conditions being studied
One study, LUCIA, is in people with wet age-related macular degeneration (wAMD). 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). 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. 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. The source data does not give more details about the visit schedule or other study procedures.
The three studies are all Phase 3 trials. 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. 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). 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. 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. 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.
- CAPRI is a Phase 3 study in diabetic macular edema with 240 planned participants.
- COMO is a Phase 3 study in diabetic macular edema with 240 planned participants.
- All three studies compare VOROLANIB with aflibercept and measure vision benefit over 56 weeks.