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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
Awards & highlights
AMEND Trial Summary
This trial will test an oral capsule to see if it can prevent vision loss in high-risk eyes.
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.Check my eligibility
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.See study design
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.
AMEND Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Area under the curve for BCVA letters
Change from Baseline in BCVA
Change from Baseline in LLVA
+8 moreOther outcome measures
Changes from baseline in gut microbiota
AMEND 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
Find a Location
Who is running the clinical trial?
Smilebiotek Zhuhai LimitedLead Sponsor
2 Previous Clinical Trials
189 Total Patients Enrolled
Yang XuStudy DirectorGeneral Manager
1 Previous Clinical Trials
30 Total Patients Enrolled
Lai Wei, MDPrincipal InvestigatorChief Scientific Officer
4 Previous Clinical Trials
1,166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am blind in one eye but can see well with my other eye.I am 50 years old or older.My blood, liver, kidney, and clotting tests are within normal ranges.I have advanced AMD with specific eye changes as outlined.I had major surgery less than 30 days ago.My eyes can be clearly imaged for a retina exam.I have a missing lens or back part of the lens in my eye.I can take pills and am willing to track my medication intake daily.I have received gene therapy for a condition in the past.My eye condition has been confirmed by a retina specialist.My eye condition developed between my first and second visits.I had eye surgery to replace a lens within the last 3 months.I am 50 years old or older.I have had eye surgery or have a condition like a macular hole.I might need eye surgery during the study.I have been diagnosed with advanced age-related macular degeneration.I have an eye infection inside my eyeball.I am not willing to stop taking AREDS vitamins during the study.I have never used FDA-approved treatments for GA in my affected eye.My eye has specific types of damage due to AMD, not affecting my central vision.I can take pills and am willing to track my medication intake daily.
Research Study Groups:
This trial has the following groups:- Group 1: QA102 200mg group
- Group 2: QA102 400mg group
- Group 3: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05536752 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have registered for this research endeavor?
"Correct. The information posted on clinicaltrials.gov confirms that the trial, which was initially published on September 22nd 2022, is actively seeking participants. A total of 240 patients need to be enrolled from one medical facility."
Answered by AI
Are there currently opportunities to join this experiment?
"Affirmative. Evidenced on clinicaltrials.gov, this research is currently seeking participants having been initially posted on September 22nd 2022 and recently updated October 31st 2022. In total, 240 participants need to be enrolled from one medical centre."
Answered by AI
Has QA102 200mg group received authorization from the FDA?
"Our experts at Power have rated the safety of QA102's 200mg dose a 2, as Phase 2 trials only provide limited data on its efficacy and some documentation regarding its safety."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
California
Other
Texas
What site did they apply to?
Texas Retina Associates - Plano
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
Why did patients apply to this trial?
I have a daughter who lives in Plano that I can stay with. Since turning.40 I'm now 53 it seems my vision is getting worse and worse every week.
PatientReceived 2+ prior treatments
I have a daughter who lives in Plano that I can stay with. I want to inhibit the growth of drusen in my eye due to stargardt disease.
PatientReceived 2+ prior treatments
I have AMD and want to: 1) keep it from progressing if I can, and 2) help us all to find ways to treat and even lessen the risk of AMD. I am at high risk of going blind from AMD. My mother and all 3 of her sisters had AMD, but my sisters and cousins to not.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Texas Retina Associates - Plano: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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