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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the new oral treatment, QA102, for individuals with dry age-related macular degeneration (AMD), a condition that impairs vision. Researchers aim to determine if QA102 can slow or halt the growth of soft drusen (tiny yellow deposits under the retina), preserve vision, and prevent further eye damage. The study includes three groups: two will receive different doses of QA102, and one will receive a placebo (a dummy treatment with no active drug). Individuals with intermediate to advanced dry AMD, particularly those showing signs like drusen or specific patterns of eye damage, may be suitable candidates for this trial. As a Phase 2 trial, the study focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that QA102 has been tested for safety in earlier studies. In one study, researchers administered QA102 to both younger and older adults. The results indicated that most participants tolerated the treatment well. No major safety issues emerged, making it a promising option. Some mild side effects, such as headaches and mild stomach discomfort, were noted, but these were not serious enough to discontinue treatment.

It's important to remember that QA102 remains in the early stages of research for treating age-related macular degeneration. More information is needed about its long-term safety and effects. However, initial findings suggest it could be a safe option for many people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

Researchers are excited about QA102 for age-related macular degeneration because it offers a new approach compared to current treatments like anti-VEGF injections. Unlike these standard treatments, which focus on inhibiting blood vessel growth in the eye, QA102 is an oral medication that aims to address the underlying cellular processes contributing to the degeneration. This not only provides a more convenient administration method (pills instead of injections) but also has the potential to target the disease more comprehensively. With its unique mechanism and delivery, QA102 could significantly improve the quality of life for patients while offering more durable and effective results.

What evidence suggests that QA102 might be an effective treatment for age-related macular degeneration?

Research has shown that QA102, which participants in this trial may receive, might help treat dry age-related macular degeneration (AMD) by targeting the deposits in the eye linked to the disease. Studies suggest that QA102 slows or stops the growth of harmful bacteria in the eye, potentially reducing damage. Specifically, previous patients demonstrated fewer soft drusen (yellow deposits in the eye) and improved vision sharpness with this treatment. Additionally, QA102 has shown promise in reducing areas of cell loss in the retina and preventing abnormal blood vessel growth. These findings offer hope that QA102 could effectively slow the progression of dry AMD. ^{2 3 6 7 8}

Who Is on the Research Team?

Yang Xu

Principal Investigator

General Manager

Lai Wei, MD

Principal Investigator

Chief Scientific Officer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05536752

QA102 Phase II Study in Subjects With Dry AMD The primary objective of the study is to evaluate the efficacy of QA102 oral capsules on the development of soft drusen, visual acuity (VA), and geographic ...

2. retinalphysician.com retinalphysician.com/issues/2023/may/clinical-trial-update/

Clinical Trial Update May 2023 DRY AMD. Study: QA102 Phase II Study in ... outcomes in persistent subretinal eye fluid in neovascular wet age-related macular degeneration.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9414333/

Recent Advances in Age-Related Macular Degeneration ... This review aims to bring together the most recent advances and insights into the mechanisms underlying AMD pathogenicity and disease evolution.

4. ming-med.com ming-med.com/en/eyes/

Ophthalmic drugs - QA102 QA102 is a small molecule drug that potentially treats dry AMD by killing or inhibiting the growth of intraocular bacteria, based on the association of ...

5. withpower.com withpower.com/trial/phase-2-dry-age-related-macular-degeneration-8-2022-0e815

QA102 for Age-Related Macular Degeneration 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, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04894071

QA102 Phase 1 Study in Healthy Young and Older Adult ... This may be indicated by a specific age or the following age groups: The age groups are: Child (birth-17); Adult (18-64); Older Adult (65+) ... A measure of all ...

7. synapse.patsnap.com synapse.patsnap.com/drug/a8fd6cabb2644292b080fcdfd01a1ac7

QA-102 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, ...

8. retinalphysician.com retinalphysician.com/issues/2024/september/clinical-trial-update/

Clinical Trial Update September 2024 This is a phase 1/2 study to assess the safety and efficacy of OCU410 for geographic atrophy secondary to dry age-related macular degeneration (AMD).