What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF injections and photodynamic therapy. Anti-VEGF treatments, such as ranibizumab and aflibercept, can cause side effects like eye pain, increased intraocular pressure, and rare instances of retinal detachment or endophthalmitis. Photodynamic therapy may lead to photosensitivity reactions, temporary vision changes, and inflammation. The specific side effects of emerging treatments like Tinlarebant (LBS-008) are still under investigation, but monitoring for adverse reactions is crucial during clinical trials.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies. These include drugs like Ranibizumab (Lucentis), Aflibercept (Eylea), and Bevacizumab (Avastin), which work by inhibiting the growth of abnormal blood vessels in the retina. Another notable approval is Brolucizumab (Beovu), which also targets VEGF but offers a longer duration of action. Additionally, the FDA has approved photodynamic therapy with Verteporfin (Visudyne) for certain types of AMD. These treatments aim to slow disease progression and improve vision outcomes in patients with AMD.

What other types of research exist?

Promising novel alternatives to Tinlarebant for AMD patients include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials for neovascular AMD. 2) Gene therapy options like RGX-314, which aims to provide sustained anti-VEGF therapy through a single injection. 3) Complement inhibitors such as Pegcetacoplan, which targets C3 and has shown efficacy in reducing geographic atrophy progression in AMD.

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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

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.

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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

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