What is the mechanism of action of this treatment?

Common treatments for Age-Related Macular Degeneration (AMD), particularly dry AMD, often focus on slowing the progression of the disease and preserving vision. These treatments include antioxidant vitamins and minerals (such as those in the AREDS2 formula), which help reduce oxidative stress and inflammation in the retina. Emerging therapies, like the QA102 oral capsules, aim to target specific pathways involved in the formation of drusen and geographic atrophy, potentially slowing disease progression. These treatments are crucial for AMD patients as they can help maintain visual function and quality of life by delaying the onset of severe vision loss.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD), particularly those aimed at dry AMD, include antioxidant vitamins and minerals, such as those found in the AREDS (Age-Related Eye Disease Study) formulation. These treatments are generally well-tolerated but can sometimes cause gastrointestinal issues, such as nausea or upset stomach. High doses of certain vitamins, like vitamin E, may interfere with blood clotting and increase the risk of hemorrhage. Other potential side effects include headaches and dizziness. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), particularly for the wet form of the disease, including anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). For dry AMD, the focus has been on managing the progression of geographic atrophy (GA) and drusen. While there are no FDA-approved oral treatments specifically for dry AMD, ongoing research, such as the QA102 oral capsules trial, aims to evaluate the efficacy of new oral medications in slowing the progression of dry AMD by targeting drusen development, visual acuity, and the progression of GA or CNV.

What other types of research exist?

Promising novel alternatives to QA102 oral capsules for the treatment of dry AMD include: 1) Gene therapy such as voretigene neparvovec (Luxturna), which has shown efficacy in treating inherited retinal dystrophies and may have potential applications in AMD. 2) Intravitreal injections of anti-VEGF agents, which are being explored for their potential to slow the progression of geographic atrophy in dry AMD. 3) Emerging oral treatments like ALK-001, a deuterated form of vitamin A, which is currently in clinical trials and aims to reduce the accumulation of toxic vitamin A byproducts in the retina. 4) Complement inhibitors such as pegcetacoplan, which target the complement system involved in the pathogenesis of AMD and are undergoing clinical evaluation.

← Back to Search

Unknown

QA102 for Age-Related Macular Degeneration (AMEND Trial)

Phase 2

Waitlist Available

Led By Lai Wei, MD

Research Sponsored by Smilebiotek Zhuhai Limited

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 month 1,2,3,6,9,12,15

Summary

This trial is testing a new pill called QA102 to help people with a serious eye condition called dry AMD. The pill aims to clear up deposits in the eye, improve vision, and stop the condition from getting worse. The study will compare the effects of QA102 over several months.

Who is the study for?

This trial is for people aged 50 or older with advanced age-related macular degeneration (AMD) in one eye and at risk of AMD in the other. Participants must be able to take oral medication, have good overall health, and commit to study procedures. They can't join if they've had recent major surgery, certain eye treatments, gene therapy, or are unwilling to stop taking specific vitamins.

What is being tested?

The study tests QA102 oral capsules against a placebo to see if they prevent the development of geographic atrophy (GA) or choroidal neovascularization (CNV), which are complications of AMD. It's a phase II trial where participants don't know if they're getting the real treatment or a dummy pill.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include typical reactions from taking oral medications such as stomach upset, allergic reactions, or other systemic effects depending on how QA102 works in the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1,2,3,6,9,12,15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1,2,3,6,9,12,15

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1,2,3,6,9,12,15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Area under the curve for BCVA letters

Change from Baseline in BCVA

Change from Baseline in LLVA

+8 more

Other study objectives

Changes from baseline in gut microbiota

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: QA102 400mg groupExperimental Treatment1 Intervention

Subjects randomized to this arm will receive two (2) 200 mg capsules of QA102 BID = daily dose of 800 mg QA102 for up to 15 months

Group II: QA102 200mg groupExperimental Treatment1 Intervention

Subjects randomized to this arm will receive one (1) 200 mg capsule of QA102 and 1 placebo capsule BID = daily dose of 400 mg QA102 for up to 15 months

Group III: Placebo groupPlacebo Group1 Intervention

Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 15 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

QA102

2021

Completed Phase 1

~70

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), particularly dry AMD, often focus on slowing the progression of the disease and preserving vision. These treatments include antioxidant vitamins and minerals (such as those in the AREDS2 formula), which help reduce oxidative stress and inflammation in the retina. Emerging therapies, like the QA102 oral capsules, aim to target specific pathways involved in the formation of drusen and geographic atrophy, potentially slowing disease progression. These treatments are crucial for AMD patients as they can help maintain visual function and quality of life by delaying the onset of severe vision loss.