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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

PHOENIX Trial Summary

This trial will test if a new drug called tinlarebant is safe and effective in treating people with Geographic Atrophy (GA).

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.Check my eligibility

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.See study design

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.

PHOENIX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size

Secondary outcome measures

To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)

To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale

Other outcome measures

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

PHOENIX Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LBS-008, TinlarebantExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Belite Bio, IncLead Sponsor

5 Previous Clinical Trials

243 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I join the program to evaluate this therapy?

"To be included in this trial, potential participants must have age-related macular degeneration and lie within the 60 to 85 year old demographic. This endeavor is currently looking for around 429 volunteers."

Answered by AI

Has the FDA sanctioned LBS-008, Tinlarebant for distribution?

"The safety of LBS-008, Tinlarebant, is rated as a 3 based on prior clinical data that supports both its efficacy and multiple levels of security."

Answered by AI

Are participants of over two decades eligible for this investigation?

"According to the entrance requirements for this medical experiment, participants should fall between 60 and 85 years of age."

Answered by AI

Does this research endeavor still accept new participants?

"The clinical trial is presently recruiting, it originally appeared on the 31st of July 2023 and was last updated 10 days later. This information can be found on clinicaltrials.gov."

Answered by AI

What is the limit to how many participants can register for this clinical trial?

"Affirmative. A glance at the data hosted on clinicaltrials.gov appears to show that this medical trial, first published in July 31st 2023 is still recruiting patients. It requires 429 individuals from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

2023. "Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05949593.

All > Geographic Atrophy