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Tinlarebant for Age-Related Macular Degeneration (PHOENIX Trial)

Phase 3
Recruiting
Research Sponsored by Belite Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to month 24
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new pill called tinlarebant in people with Geographic Atrophy, an eye condition that causes vision loss. The goal is to see if the pill can help slow down or stop the progression of the disease.

Who is the study for?
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.
What is being tested?
The trial is testing Tinlarebant against a placebo to see if it's safe and effective for treating GA. Participants are randomly assigned to receive either Tinlarebant or a placebo without knowing which one they're getting.
What are the potential side effects?
While specific side effects for Tinlarebant aren't listed here, common side effects in trials like this may include irritation at the site of injection, headache, nausea, and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
To evaluate the correlation between the reduction of serum RBP4 and the growth of atrophic lesions (DDAF)
To measure changes in contrast sensitivity as assessed using the Pelli-Robson Contrast Sensitivity Chart (or any assessment deemed acceptable by study sites)
To measure changes in retinal sensitivity as assessed by microperimetry

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LBS-008, TinlarebantExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapies, which inhibit the growth of abnormal blood vessels in the retina to prevent leakage and vision loss, and photodynamic therapy, which uses a photosensitizing agent and light to destroy these vessels. Emerging treatments like Tinlarebant (LBS-008) likely target similar pathways to prevent retinal damage. Understanding these mechanisms is crucial for AMD patients to select the most appropriate treatment to slow disease progression and preserve vision.

Find a Location

Who is running the clinical trial?

Belite Bio, IncLead Sponsor
6 Previous Clinical Trials
303 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05949593 — Phase 3
Age-Related Macular Degeneration Research Study Groups: Placebo, LBS-008, Tinlarebant
Age-Related Macular Degeneration Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05949593 — Phase 3
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05949593 — Phase 3
~286 spots leftby Aug 2027