Intermediate Age-Related Macular DegenerationPhase 3NCT07189169
QA108 Phase III Study in Subjects With Intermediate AMD
A Phase 3 study testing QA108 granules in people with Intermediate Age-Related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 1 site in China.
Trial summary
This is a phase III randomized, double-masked, placebo-controlled, multicenter study. To evaluate the efficacy and safety of QA108 granules in the treatment of intermediate age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Intermediate Age-Related Macular Degeneration
- What is being tested?
- QA108 granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration;
- Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus;
- Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- Age 45-85 years (inclusive), regardless of gender;
- The study eye has a BCVA of 88-34 letters (using the ETDRS chart, inclusive of threshold values), equivalent to a Snellen visual acuity of 20/20 to 20/200 (inclusive);
- Voluntary participation in this clinical trial, with informed consent provided and an informed consent form signed
Who cannot join
- The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macular hole;
- The study eye has an intraocular pressure (IOP) ≥ 25 mmHg;
- Presence of geographic atrophy (GA) involving the foveal center in the study eye;
- Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;
- Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) of the study eye;
- Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months;
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- Cataract in the study eye that interferes with fundus examination or imaging;
- Treatments received in the study eye within 3 months prior to screening, including macular laser photocoagulation and micropulse laser therapy;
- The patient received relevant TCM treatment within 1 month prior to screening;
- Active ocular infection in either eye that affects fundus examination or imaging;
- The non-study eye has a BCVA of less than 19 ETDRS letters (not inclusive);
- Known allergy to the therapeutic or diagnostic drug used in the study protocol, including the single drug components in the study drugs;
- Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after regular use of antihypertensive drugs);
- Platelet count ≤100×10⁹/L (unless follow-up results are normal), or any of the following exceeding 1.5 times the upper limit of normal (ULN): total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine (Cr);
- Pregnant women, women who are breastfeeding, those who plan for pregnancy in the next six months, or those who are unwilling to take effective birth controls during the study course and until six months after drug withdrawal;
- Any uncontrollable clinical disorder prior to the start of treatment, such as severe psychiatric, neurological, respiratory, immunological, hematological, and cardiac system diseases, and malignant tumors;
- Subjects who have participated in other clinical trials within 3 months prior to this trial;
- Patients who are unsuitable for participating at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing
hong Dai, 010-85132171, Dai-hong@x263.net
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration (Type of Yang-Hyperactivity Due to Yin-Deficiency)
This is a phase III randomized, double-masked, placebo-controlled, multicenter study. To evaluate the efficacy and safety of QA108 granules in the treatment of intermediate age-related macular degeneration.
- Being tested
- QA108 granules, QA108 granules placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QA108 granulesDrug
Take the medication as required for 24 weeks
QA108 granules placeboDrug
Take the medication as required for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| QA108 granules, 7.5 g/bag,2 bags/time, BID | Experimental | Not described Receives: Drug: QA108 granules |
| QA108 granule simulants, 7.5 g/bag,2 bags/time, BID | Placebo comparator | Not described Receives: Drug: QA108 granules placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in drusen area
Measured: weeks 24
Secondary outcomes (1)
Percentage change from baseline in drusen area
Measured: weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start8 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smilebiotek Zhuhai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189169
- Sponsor's protocol ID
- QA108-III
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration (Type of Yang-Hyperactivity Due to Yin-Deficiency)
- ClinicalTrials.gov ID
- NCT07189169
- Acronym / sponsor ID
- QA108-III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Smilebiotek Zhuhai LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III randomized, double-masked, placebo-controlled, multicenter study. To evaluate the efficacy and safety of QA108 granules in the treatment of intermediate age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QA108 granules, 7.5 g/bag,2 bags/time, BID | Experimental | Drug: QA108 granules |
| QA108 granule simulants, 7.5 g/bag,2 bags/time, BID | Placebo comparator | Drug: QA108 granules placebo |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration;
- Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus;
- Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- Age 45-85 years (inclusive), regardless of gender;
- The study eye has a BCVA of 88-34 letters (using the ETDRS chart, inclusive of threshold values), equivalent to a Snellen visual acuity of 20/20 to 20/200 (inclusive);
Key exclusion criteria (18 listed)
- The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macular hole;
- The study eye has an intraocular pressure (IOP) ≥ 25 mmHg;
- Presence of geographic atrophy (GA) involving the foveal center in the study eye;
- Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;
- Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) of the study eye;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QA108 granulesTake the medication as required for 24 weeks | Drug | QA108 granules, 7.5 g/bag,2 bags/time, BID |
| QA108 granules placeboTake the medication as required for 24 weeks | Drug | QA108 granule simulants, 7.5 g/bag,2 bags/time, BID |
Primary outcome
Percentage change from baseline in drusen area
Time frame: weeks 24
1 secondary outcome
Percentage change from baseline in drusen area
Time frame: weeks 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QA108 granules in people with Intermediate Age-Related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 1 site in China.
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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Dai (010-85132171, Dai-hong@x263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in drusen area (time frame: weeks 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.