Clinical Study on the Efficacy and Safety of BAT5906 Injection

NCT05141994 | Completed Phase 2

• 1 other identifier: BAT5906-002-CR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 16

Brief Summary

This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Dose-response relationships

  Trend chart of changes in the best corrected visual acuity from baseline

  week 24

Secondary Outcomes (4)

• BCVA

  week 12 ，week 48

• CRT

  week 12 ，week 24，week 48

• 95% confidence interval

  week 12 ，week 24，week 48

• Average times of administration

  week 24，week 48

Other Outcomes (11)

• Pharmacokinetic（Cmax）

  up tp week 48

• Pharmacokinetic（Tmax）

  up tp week 48

• Pharmacokinetic（AUC0-Tau）

  up tp week 48

Study Arms (2)

2.5mg of BAT5906

EXPERIMENTAL

Specification: 10mg/0.2ml/piece; route: intravitreal injection; dose: 2.5mg/eye/time, 50μl; medication duration: about once every 4 weeks, taking 3 times after continuous use, effective observation to Week 48.

Drug: 2.5mg of BAT5906

4.0mg of BAT5906

EXPERIMENTAL

16mg/0.2ml/piece; route of administration: intravitreal injection; dose: 4.0mg/eye/time, 50μl; duration of administration: once every 4 weeks, 3 times after continuous administration , The effectiveness was observed to the 48th week.

Drug: 4mg of BAT5906

Interventions

2.5mg of BAT5906 DRUG

Specification: 2.5mg of BAT5906

2.5mg of BAT5906

4mg of BAT5906 DRUG

Specification: 4mg of BAT5906

4.0mg of BAT5906

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only the following criteria are met:
• The patient or his legal representative authorized by the patient signs the informed consent, fully understands the test content, process and possible adverse reactions, and is willing to follow up within the time specified in the test;
• Age 50-85 years old (including boundary value), male or female;
• The patient diagnosed with active choroidal neovascularization (CNV) disease secondary to wet age-related macular degeneration is confirmed by the reading center during screening;
• The total area of research eye lesions ≤ 30mm2 (12 optic disc areas), confirmed by the reading center before random enrollment;
• At the time of screening and baseline, the BCVA of the study eye was 73-24 letters (using the ETDRS visual acuity table, including the boundary value) (equivalent to the snellen visual acuity score of the study eye of 20/40 to 20/400);
• At the time of screening and baseline, the contralateral eye BCVA ≥ 34 letters (using the ETDRS visual acuity table, which is equivalent to snellen vision ≥ 20/200). For the subjects in the PK group, the investigator must judge that the contralateral eye is expected to be 3 No anti-VEGF treatment is required within a month.

You may not qualify if:

• If a patient meets any of the following conditions, they cannot enter the study:
• Those with the following eye conditions:
• The research eye has map-like atrophy involving the fovea, scars or fibrosis, anterior macular membrane, dense exudate hard exudation, RPE tear, etc. (confirmed by the reading center during screening);
• Research eye retinal hemorrhage ≥ 4 optic disc areas (confirmed by the reading center during screening);
• The research eye has significant interference with vision detection, anterior segment and fundus assessment of the refractive medium is turbid or the pupil is not dilated;
• The research eye is combined with other fundus diseases (such as diabetic retinal degeneration, retinal vein occlusion, vascular streaking, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);
• The research eye has pupil afferent defects (APD)
• There are uncontrolled glaucoma in the research eye at the time of screening and baseline, defined as the intraocular pressure is still higher than 21mmHg after drug treatment, or according to the investigator's judgment;
• The pre-screening research eye had received dexamethasone intravitreal implant (Ozurdex) treatment or fluocinolone intravitreal implant (Iluvien) treatment;
• Within 3 months before the screening, the research eye had received the following treatments: photodynamic therapy (PDT), total retina laser photocoagulation, macular laser photocoagulation, transpupillary thermotherapy, etc., for AMD therapy;
• The research eye has undergone the following ophthalmic operations: vitrectomy, macular transposition, anti-glaucoma surgery;
• Have undergone external eye surgery or cataract surgery within 3 months before the study eye screening or during the study period;
• The study eye has no lens (excluding intraocular lens) or posterior lens capsule rupture (except YAG laser posterior capsulotomy after implantation of intraocular lens more than 1 month after screening);
• Contralateral eye received photodynamic (PDT) treatment within 1 month before screening;
• A history of uveitis in any eye;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (16)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

Eye Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Jieyang People's Hospital

Jieyang, China

Location

The First Hospital of Jilin University

Jilin, China

Location

he Affiliated Eye Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, China

Location

West China Hospital of Sichuan University

Sichuan, China

Location

Wenzhou Medical University Affiliated Optometry Hospital

Wenzhou, China

Location

The Second Xiangya Hospital of Central South University

Xiangya, China

Location

Henan Provincial Eye Hospital

Zhengzhou, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Study Officials

• Youxin Chen

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: December 2, 2021
• Study Start: August 26, 2020
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (16)