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Dry Age-related Macular DegenerationPhase 2AMENDNCT05536752

QA102 Phase II Study in Subjects With Dry AMD

A Phase 2 study testing QA102 in people with Dry Age-related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. 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 atrophy (GA) or choroidal neovascularization (CNV) or the progression of GA… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dry Age-related Macular Degeneration
What is being tested?
QA102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
29 sitesUnited States
Study dates
22 Sep 2022to 12 Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be able to understand and willing to sign a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
  • Subject must be age ≥50 years at the time of informed consent.
  • Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.
  • Subject must have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.
  • Subject must be willing and able to comply with study procedures and examinations.
  • Specific to the Study Eye:
Show all 14Show fewer
  • Subject must have one of the following:
  • extensive intermediate-size drusen, or at least 1 large drusen, or
  • GA ((not involving the foveal center point) secondary to AMD, with very limited aggregate size of total GA(s), as defined in the protocol.
  • Subject must be able to correctly identify ≥35 ETDRS letters (approximately 20/200 Snellen equivalent).
  • Specific to Fellow Eye:
  • Subject must have a diagnosis of advanced AMD (evidence of GA and/or CNV), to be confirmed by the CRC.
  • Specific to Both Eyes:
  • Subject must have visualizable retina, clear ocular media, and adequate pupillary dilation to ensure high-quality fundus imaging.

Who cannot join

  • Subject received an active investigational drug within 6 weeks (or 5 half-lives of the active, whichever is longer) prior to screening for this QA102 study.
  • Subject has ever received gene therapy (for any condition).
  • Subject is unwilling to stop intake of Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study.
  • Subject has a clinically significant systemic disease that might interfere with the study, in the judgment of the Investigator.
  • Subject had major surgery within 30 days prior to Screening.
  • Specific to Study Eye:
Show all 19Show fewer
  • Subject has large GA, subfoveal GA, or active or inactive CNV, as confirmed by the CRC.
  • Subject has GA or CNV due to causes other than AMD that that developed between Visit 1 (Screening) and Visit 2 (Randomization).
  • Subject has endophthalmitis.
  • Subject has a hemorrhagic or serous pigment epithelial detachment (PED) within 500 µm of the foveal center point, to be confirmed by the CRC.
  • Subject has had retinal procedures or surgeries, or has a retinal pathology, such as a macular hole.
  • Subject has aphakia or absence of the posterior capsule.
  • Subject has ever received, whether in an interventional trial or by prescription, an FDA- approved treatment for GA. Use of such treatment during the QA102 study period also is prohibited. (Study Eye Only)
  • Specific to Fellow Eye:
  • Subject has monocular vision impairment, defined as having no light perception in the fellow eye with adequate vision in the study eye.
  • Specific to Either Eye:
  • Subject had intraocular surgery with lens replacement within 3 months of Screening.
  • Subject has any ophthalmic condition that could require surgery during the study period.
  • Subject has an ocular condition that might affect adequate imaging of the retina and/or or alter visual acuity.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Velocity Clinical Research

    Cincinnati, Ohio, 45202

  • Retina Consultants of Southern Colorado, P.C.

    Colorado Springs, Colorado, 80909

  • AXIS Clinicals LLC / Retina of North Texas

    Dallas, Texas, 75243

  • Advanced Research

    Deerfield Beach, Florida, 33064

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • MedEye Associates

    Miami, Florida, 33143

  • Northern California Retina Vitreous Associates Medical Group

    Mountain View, California, 94040

  • University Retina and Macula Associates

    Oak Forest, Illinois, 60452

  • California Eye Specialists Medical Group

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Associated Retina Consultants

    Phoenix, Arizona, 85021

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Texas Retina Associates - Plano

    Plano, Texas, 75075

  • California Eye Specialists Medical Group

    Redlands, California, 91107

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Retina Research Institute

    St Louis, Missouri, 63144

  • Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

  • Vitreous and Retina Consultants

    Winter Haven, Florida, 33880

  • Vitreo-Retinal Associates, P.C.

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Efficacy of QA102 in Subjects With Dry Age-Related Macular Degeneration (AMD)

This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. 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 atrophy (GA) or choroidal neovascularization (CNV) or the progression of GA in subjects with intermediate to advanced dry AMD.

Read the detailed description

Approximately 30 sites will randomize a total of approximately 150 subjects to 1 of 3 treatment arms in a 1:1:1 ratio (50 subjects per arm). Each subject will receive either QA102 or matching placebo BID for up to 15 months.

Being tested
QA102/Placebo, QA102, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QA102/PlaceboDrug

    Capsules

  • QA102Drug

    Capsules

  • PlaceboDrug

    Capsules

Study groups in NCT05536752
Study groupRoleWhat they receive
QA102 200mg groupExperimentalSubjects 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
Receives: Drug: QA102/Placebo
QA102 400mg groupExperimentalSubjects 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
Receives: Drug: QA102
Placebo groupPlacebo comparatorSubjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 15 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Soft Drusen Volume (mm3)

    Change from baseline in soft drusen volume (mm3), Efficacy-Evaluable Analysis Set

    Measured: Month 12

Secondary outcomes (1)

  1. Mean Rate of GA Growth

    Mean Rate of Growth in GA (mm2) (Square Root Transformation) from Baseline

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start22 Sep 2022
  3. Primary completion12 Nov 2024
  4. Study completion12 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536752
Sponsor's protocol ID
QA102-CS201
Acronym
AMEND
Status last verified
Sep 2026
First submitted
8 Sep 2022
Last updated
1 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QA102 in people with Dry Age-related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Soft Drusen Volume (mm3) (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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