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New treatment option for Intermediate Age-Related Macular Degeneration
Official title QA108 Phase III Study in Subjects With Intermediate AMD
ClinicalTrials.gov ID: NCT07189169
What this study is testing
What is QA108 granules?
QA108 granules is an investigational medicine, being studied as a potential treatment for intermediate age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85
You may be able to join if
- 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...
You likely can't join if
- The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including...
- 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...
- Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months;
See the full eligibility criteria
- 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
- 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...
- 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;
- 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...
- 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...
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.