QA108 Phase II Study in Subjects With Intermediate Age-Related Macular Degeneration

Last updated: July 12, 2024
Sponsor: Smilebiotek Zhuhai Limited
Overall Status: Completed

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

QA108 granules

QA108 granules placebo

Clinical Study ID

NCT05562219
QA108
  • Ages 45-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The study eye is diagnosed by western medicine with intermediate age-related maculardegeneration, i.e., at least one large drusen (≥ 125 μm in diameter) is visiblewithin two papillary diameters (PD) away from the fovea;

  2. Consistent with the TCM diagnosis of type of Yang-hyperactivity due toYin-deficiency;

  3. Age 45 to 85 years old (both inclusive), male or female;

  4. The study eye has a BCVA of 83-34 ETDRS letters (inclusive), which is equivalent toa Snellen visual acuity of 20/25 to 20/200 (inclusive);

  5. The subject is voluntary to participate in this clinical study, provide informedconsent, and sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. The study eye is with concomitant eye disorders that may interfere with theobservation of the trial as judged by the investigator, including pathologicalmyopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinaldetachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macularhole;

  2. The study eye has an intraocular pressure (IOP) ≥ 25 mmHg;

  3. The study eye is presented with GA;

  4. Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;

  5. Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laserposterior capsulotomy after IOL implantation at more than 1 month prior toscreening) of the study eye;

  6. Any intraocular or periocular surgery of the study eye and intraocular surgery (except eyelid surgery) of the non-study eye within 3 months;

  7. The study eye is diagnosed with cataract affecting fundus observation, which mayrequire cataract surgery within 6 months at the discretion of the investigator;

  8. The study eye has received the following treatment within 3 months prior toscreening: macular laser photocoagulation and micro-pulse laser therapy;

  9. The patient received relevant TCM treatment within 1 month prior to screening;

  10. Active ocular infection in either eye;

  11. The non-study eye has a BCVA of less than 19 ETDRS letters (not inclusive);

  12. Known allergy to the therapeutic or diagnostic drug used in the study protocol,including the single drug components in the study drugs;

  13. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolicblood pressure ≥ 100 mmHg after regular use of antihypertensive drugs);

  14. Patients with platelet count ≤ 100 × 109/L, total bilirubin (TBIL) > upper limit ofnormal (ULN), alanine transaminase (ALT) or aspartate aminotransferase (AST) > 1.5 ×ULN, and blood creatinine > ULN;

  15. Pregnant women, women who are breastfeeding, those who plan for pregnancy in thenext six months, or those who are unwilling to take effective birth controls duringthe study course and until six months after drug withdrawal;

  16. Any uncontrollable clinical disorder prior to the start of treatment, such as severepsychiatric, neurological, respiratory, immunological, hematological, and cardiacsystem diseases, and malignant tumors;

  17. Subjects who have participated in other clinical trials within 3 months prior tothis trial;

  18. Patients who are unsuitable for participating at the discretion of the investigator.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: QA108 granules
Phase: 2
Study Start date:
June 29, 2022
Estimated Completion Date:
June 24, 2024

Study 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).

Connect with a study center

  • Peking Union Medical College Hospital (PUMCH)

    Peking,
    China

    Site Not Available

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