Phase II Clinical Study on the Efficacy and Safety of BAT5906 Injection in the Vitreous Age-related Macular Degeneration Patients With Two Repeated Intravitreal Dose
Overview
- Phase
- Phase 2
- Intervention
- 2.5mg of BAT5906
- Conditions
- Wet Age-related Macular Degeneration
- Sponsor
- Bio-Thera Solutions
- Enrollment
- 48
- Locations
- 16
- Primary Endpoint
- Dose-response relationships
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
2.5mg of BAT5906
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.
Intervention: 2.5mg of BAT5906
4.0mg of BAT5906
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.
Intervention: 4mg of BAT5906
Outcomes
Primary Outcomes
Dose-response relationships
Time Frame: week 24
Trend chart of changes in the best corrected visual acuity from baseline
Secondary Outcomes
- 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)