Intermediate Age-Related Macular DegenerationPhase 2NCT05562219
QA108 Phase II Study in Subjects With Intermediate Age-Related Macular Degeneration
A Phase 2 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 2, 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2022to 24 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 is diagnosed by western medicine with intermediate age-related macular degeneration, i.e., at least one large drusen (≥ 125 μm in diameter) is visible within two papillary diameters (PD) away from the fovea;
- Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- Age 45 to 85 years old (both inclusive), male or female;
- The study eye has a BCVA of 83-34 ETDRS letters (inclusive), which is equivalent to a Snellen visual acuity of 20/25 to 20/200 (inclusive);
- The subject is voluntary to participate in this clinical study, provide informed consent, and sign the informed consent form.
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;
- The study eye is presented with GA;
- 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 or periocular surgery of the study eye and intraocular surgery (except eyelid surgery) of the non-study eye within 3 months;
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- The study eye is diagnosed with cataract affecting fundus observation, which may require cataract surgery within 6 months at the discretion of the investigator;
- The study eye has received the following treatment within 3 months prior to screening: macular laser photocoagulation and micro-pulse laser therapy;
- The patient received relevant TCM treatment within 1 month prior to screening;
- Active ocular infection in either eye;
- 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);
- Patients with platelet count ≤ 100 × 109/L, total bilirubin (TBIL) > upper limit of normal (ULN), alanine transaminase (ALT) or aspartate aminotransferase (AST) > 1.5 × ULN, and blood creatinine > ULN;
- 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.
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase II Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration
This is a phase 2, 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 the detailed description
Approximately 12 sites will randomize a total of approximately 120 subjects . The subject randomization code table is generated using block randomization. Randomization of not less than 120 cases receiving treatment (treatment and placebo groups) at a ratio of 1:1 for the treatment and control groups.
Clinic study visits will occur on Day -7 to Day -1(Screening/Baseline)(Randomization); Treatment Visits for weeks 4, 8, 12,16,20,and 24 (all ± 3 days); sites will contact each subject to update efficacy date and adverse events (AEs) and review concomitant medications (CMs).
- 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 |
|---|---|---|
| Treatment group(QA108 granules) | Experimental | QA108 granules, 7.5 g/bag,2 bags/time, BID Receives: Drug: QA108 granules |
| Placebo group(QA108 granule simulants) | Placebo comparator | QA108 granule simulants, 7.5 g/bag,2 bags/time, BID 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 .
- change from baseline in drusen area as measured by optical coherence tomography (OCT)
- assessments will be conducted by the central reading center (CRC)
Measured: weeks 24
Secondary outcomes (1)
Percentage change from baseline in drusen area
change from baseline in drusen area as measured by optical coherence tomography (OCT)
Measured: weeks 4,8,12,16,20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start29 Jun 2022
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smilebiotek Zhuhai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562219
- Sponsor's protocol ID
- QA108
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2022
- Last updated
- 15 Jul 2024
- 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase II Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05562219
- Acronym / sponsor ID
- QA108
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Smilebiotek Zhuhai LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 30 Sep 2022 (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 2, 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.
Detailed description
Approximately 12 sites will randomize a total of approximately 120 subjects . The subject randomization code table is generated using block randomization. Randomization of not less than 120 cases receiving treatment (treatment and placebo groups) at a ratio of 1:1 for the treatment and control groups.
Clinic study visits will occur on Day -7 to Day -1(Screening/Baseline)(Randomization); Treatment Visits for weeks 4, 8, 12,16,20,and 24 (all ± 3 days); sites will contact each subject to update efficacy date and adverse events (AEs) and review concomitant medications (CMs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group(QA108 granules) | Experimental | Drug: QA108 granulesQA108 granules, 7.5 g/bag,2 bags/time, BID |
| Placebo group(QA108 granule simulants) | Placebo comparator | Drug: QA108 granules placeboQA108 granule simulants, 7.5 g/bag,2 bags/time, BID |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The study eye is diagnosed by western medicine with intermediate age-related macular degeneration, i.e., at least one large drusen (≥ 125 μm in diameter) is visible within two papillary diameters (PD) away from the fovea;
- Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- Age 45 to 85 years old (both inclusive), male or female;
- The study eye has a BCVA of 83-34 ETDRS letters (inclusive), which is equivalent to a Snellen visual acuity of 20/25 to 20/200 (inclusive);
- The subject is voluntary to participate in this clinical study, provide informed consent, and sign the informed consent form.
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;
- The study eye is presented with GA;
- 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 | Treatment group(QA108 granules) |
| QA108 granules placeboTake the medication as required for 24 weeks | Drug | Placebo group(QA108 granule simulants) |
Primary outcome
Percentage change from baseline in drusen area .
Time frame: weeks 24
1. change from baseline in drusen area as measured by optical coherence tomography (OCT) 2. assessments will be conducted by the central reading center (CRC)
1 secondary outcome
Percentage change from baseline in drusen area
Time frame: weeks 4,8,12,16,20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 5 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: finished, as of the sponsor's last update on 15 Jul 2024. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 15 Jul 2024; AzTrials last refreshed its copy on 2 Nov 2026.