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

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.

Study Overview

• Status: Recruiting
• Conditions: Intermediate Age-Related Macular Degeneration
• Intervention / Treatment: Drug: QA108 granules; Drug: QA108 granules placebo

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: youxin chen; Phone Number: 010-6915 6351; Email: chenyouxinpumch@163.com

Study Locations

• China
  • Peking, China
    • Recruiting
    • Peking Union Medical College Hospital (PUMCH)
    • Contact: youxin chen; Phone Number: 010 6915 6351; Email: chenyouxinpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-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 to a Snellen visual acuity of 20/25 to 20/200 (inclusive);
5. The subject is voluntary to participate in this clinical study, provide informed consent, and sign the informed consent form.

Exclusion Criteria:

1. 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;
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 laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) 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 may require cataract surgery within 6 months at the discretion of the investigator;
8. The study eye has received the following treatment within 3 months prior to screening: 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 diastolic blood pressure ≥ 100 mmHg after regular use of antihypertensive drugs);
14. 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;
15. 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;
16. 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;
17. Subjects who have participated in other clinical trials within 3 months prior to this trial;
18. Patients who are unsuitable for participating at the discretion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group(QA108 granules); QA108 granules, 7.5 g/bag,2 bags/time, BID	Drug: QA108 granules; Take the medication as required for 24 weeks
Placebo Comparator: Placebo group(QA108 granule simulants); QA108 granule simulants, 7.5 g/bag,2 bags/time, BID	Drug: QA108 granules placebo; Take the medication as required for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	weeks 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in drusen area	change from baseline in drusen area as measured by optical coherence tomography (OCT)	weeks 4,8,12,16,20

Collaborators and Investigators

• Sponsor: Smilebiotek Zhuhai Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: QA108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No