QA102 for Age-Related Macular Degeneration

(AMEND Trial)

Overseen By Jason Herter

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Smilebiotek Zhuhai Limited

Must not be taking: AREDS vitamins

Disqualifiers: Gene therapy, Major surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study. Other medications are not specifically mentioned, so it's best to discuss with the study team.

How does the drug QA102 for age-related macular degeneration differ from other treatments?

QA102 is unique because it is being tested in combination with a placebo, which is a dummy treatment, to evaluate its effectiveness specifically for age-related macular degeneration, a condition with limited approved treatments. Unlike other emerging therapies that focus on neuroprotection, oxidative damage prevention, or inflammation suppression, QA102's specific mechanism or approach is not detailed, making it a novel candidate in the clinical trial landscape. ^{1 2 3 4 5}

Research Team

Yang Xu

Principal Investigator

General Manager

Lai Wei, MD

Principal Investigator

Chief Scientific Officer

Eligibility Criteria

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.

Inclusion Criteria

My blood, liver, kidney, and clotting tests are within normal ranges.

I have advanced AMD with specific eye changes as outlined.

My eyes can be clearly imaged for a retina exam.

Exclusion Criteria

I am blind in one eye but can see well with my other eye.

I had major surgery less than 30 days ago.

Subject has an ocular condition that might affect adequate imaging of the retina and/or alter visual acuity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QA102 or placebo BID for up to 15 months

15 months

Monthly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• QA102
• QA102/Placebo

Trial Overview 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.

Participant Groups

Group I: QA102 400mg group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Smilebiotek Zhuhai Limited

Lead Sponsor

Trials

3

Recruited

340+

Findings from Research

Emerging treatments for dry age-related macular degeneration (AMD) focus on two main strategies: preventing cell loss through neuroprotection and oxidative damage prevention, and suppressing inflammation.

Current and potential therapies include neuroprotective drugs, micronutrient supplementation, visual cycle modulators, and anti-inflammatory agents, suggesting a combination approach may be most effective in managing AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches and potential treatments for dry age-related macular degeneration. Damico, FM., Gasparin, F., Scolari, MR., et al.[2022]

In a phase 3 trial involving 366 patients with neovascular age-related macular degeneration, the biosimilar QL1207 demonstrated equivalent efficacy to the reference drug aflibercept, with a mean difference in visual acuity change of -1.1 letters, which falls within the predefined equivalence margin.

Both QL1207 and aflibercept showed similar safety profiles, with comparable rates of treatment-emergent adverse events (71.4% for QL1207 vs. 71.8% for aflibercept), indicating that QL1207 can be a safe alternative for patients requiring anti-VEGF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial. Li, B., Fan, K., Zhang, T., et al.[2023]

Wet age-related macular degeneration (AMD) is recognized as a complex disease involving not just blood vessel growth but also inflammation, prompting researchers to explore new treatments that target multiple aspects of its pathology.

Several new agents, including VEGF blockers and inflammation inhibitors, are currently in human trials or have been approved, indicating a shift towards more comprehensive treatment strategies for wet AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. Ni, Z., Hui, P.[2009]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Can HMG Co-A reductase inhibitors ("statins") slow the progression of age-related macular degeneration? The age-related maculopathy statin study (ARMSS). [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

New approaches and potential treatments for dry age-related macular degeneration. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging pharmacologic therapies for wet age-related macular degeneration. [2009]

5. China pubmed.ncbi.nlm.nih.gov

Emerging Therapies in Nonexudative Age-Related Macular Degeneration in 2020. [2021]