Tinlarebant for Age-Related Macular Degeneration
(PHOENIX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called tinlarebant for individuals with age-related macular degeneration (AMD), a condition that affects vision. The researchers aim to determine if tinlarebant can improve vision in those with geographic atrophy (GA), a specific type of AMD. Participants will receive either tinlarebant or a placebo (a substance without active medicine) to compare results. Ideal candidates for this trial are those diagnosed with GA and without other eye diseases like diabetic macular edema. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that tinlarebant is likely to be safe for humans?
Research has shown that tinlarebant has been tested for safety in conditions like Stargardt disease. In those studies, researchers closely monitored participants for side effects. The results indicated that the treatment was generally well-tolerated, with most side effects being mild.
In ongoing trials, such as the DRAGON trial, the focus remains on tinlarebant's safety. These trials suggest that while some side effects may occur, they are not severe for most people. The treatment is now in a later stage of research, having already passed earlier safety checks. This supports the idea that tinlarebant is safe for humans, but ongoing studies will provide more detailed safety information.12345Why do researchers think this study treatment might be promising for macular degeneration?
Researchers are excited about Tinlarebant because it offers a fresh approach to tackling age-related macular degeneration (AMD). Unlike standard treatments, which often involve injections into the eye to slow disease progression, Tinlarebant is an oral medication, making it potentially less invasive and more convenient for patients. It works by inhibiting the production of a toxic vitamin A derivative that contributes to AMD, aiming to protect retinal cells and preserve vision. This novel mechanism of action could offer a new hope for those with AMD, potentially reducing the need for frequent eye injections.
What evidence suggests that tinlarebant might be an effective treatment for age-related macular degeneration?
Research has shown that tinlarebant, which participants in this trial may receive, might help treat age-related macular degeneration by reducing harmful substances in the eye called bisretinoids. These substances can accumulate and cause damage. A previous study found that tinlarebant might slow the growth of damaged areas in the eye. This treatment is still under investigation in this trial, but early results suggest it could help protect vision. If successful, tinlarebant could become an important treatment for people with this eye condition.12678
Are You a Good Fit for This Trial?
This trial is for individuals with confirmed diagnosis of Geographic Atrophy (GA), a form of age-related macular degeneration, who have a certain level of vision remaining. It's not open to those with diabetic eye diseases, advanced diabetic retinopathy, other retinal vascular diseases, or uncontrolled glaucoma in the study eye.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tinlarebant or placebo orally once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Tinlarebant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Belite Bio, Inc
Lead Sponsor