Clinical trial NCT04151212: A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration
Official title: A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-related Macular Degeneration
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.

Detailed description: The primary objective: To evaluate the safety and Pharmacokinetics of BAT5906 (single-dose Ophthalmic Intracireal Iinjection) in patients wAMD , when the injection dosage escalates.

The Secondary objective: To evaluate the immunogenicity profile of BAT5906; To evaluate the pharmacodynamics and therapeutic efficacy profile of BAT5906.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 50-80 years old .
* Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
* The study eye must meet all the following inclusion criteria: To be diagnosed as wet age related macular degeneration, and there are still active lesions currently;Total lesion size of ≤30mm2( 12 disc areas);Best corrected visual acuity ≤70 Early Treatment of Diabetic Retinopathy ;Study letters (≤20/40) in the study eye.
* Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.

Exclusion Criteria:

* There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
* Retinal hemorrhage ≥4 disc area in the study eye.
* Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
* Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
* History of vitrectomy surgery\\macular transposition\\glaucoma filtration in the study eye.
* Photodynamic therapy(PDT), in macular area laser photocoagulation therapy, transpermary hyperthermia(TTT), and other operations for AMD within 3 months prior to screening visit in the study eye.
* History of extraocula surgeryr within 1 months or cataract surgery within 3 months prior to screening visit in the study eye.
* Aphakia(exclusive of intraocular lens) or rupture of posterior capsule( within1 months prior to the YAG laser retrovesiculotomy (after the artificial crystal), was excluded) in the study eye.
* APD in the study eye or pseudocyst stripping syndrome in either eye.
* Intravitrea or Systemicl anti-VEGF injection (ranibizumab, aflibercept, bevacizumab or Conbercept etc) in either eye within 3 months prior to screening visit.
* Under the conjunctiva,intravitreal or periocular corticosteroid, within 3 months prior to screening visit in either eye.
* vitreous hemorrhage within 3 months prior to screening Visit in either eye.
* Ocular or periocular infection in either eye.
* History of glaucoma in either eye.
* Visudyne (verteporfin) photodynamic therapy within 1 months prior to screening Visit in non-study eye.
* Currently in use or may be required to use systemic drugs that cause crystal toxicity or retinal toxicity, such as Deferoxamine, chloroquine/ hydroxychloroquine, phenothiazine and ethambutol or tamoxifen etc.
* Have an allergic reaction or history of allergic reactions to fluorescein sodium and indocyanine green, an allergic history to therapeutic or diagnostic protein products, an allergic reaction to more than two drugs or non-drug factors, or allergic reactions to any monoclonal antibody.
* Patients with diabetic retinopathy or the diabetic patient who have glycosylated? hemoglobin\>10%.
* Patients who have undergone any surgical operation within 1 month prior screening; or/and there are unhealed wounds, ulcers, fractures etc.
* Systemic infectious diseases with clinical significance requiring oral, intramuscular or Patients withintravenous administration.
* Myocardial infarction, cerebral infarction and angina pectoris within 6 months prior to screening visit.
* Patients with active disseminated intravascular coagulation and obvious bleeding tendency were screened within 3 months before the screening, or they were treated with anticoagulant and antiplatelet therapy other than aspirin/NSAIDs within 14 days before the screening.
* Patients with Systemic immune disease ,including but not limited to:

hyperthyroidism, hypothyroidism,vitiligo, dry-syndrome, ankylosing spondylitis, systemic nephritis, human immunodeficiency virus (HIV).

* Blood pressure control is not ideal or pre-hypertension.
* Any uncontrollable clinical problems (Serious mental, nervous, cardiovascular and respiratory diseases and malignant tumors).
* Abnormal liver and kidney function.
* Blood coagulation is abnormal.
* Patients with AIDS, syphilis or active hepatitis.
* Women are not using effective contraception or in pregnancy,lactation.
* Clinical trials of any trial medication or any other experimental or experimental therapy may be performed within 3 months prior to screening.
* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Primary outcomes:
measure: Dose-limiting toxicity(DLT)
timeFrame: 2 weeks
measure: Maximum tolerated dosed(MTD)
timeFrame: 0-70days
measure: Area under the curve(AUC0-t, AUC0-inf)
timeFrame: 0-70days
measure: Maximum serum drug concentration(Cmax)
timeFrame: 0-70days
measure: Half-life period(t1/2)
timeFrame: 0-70days
measure: Maximum serum drug time(Tmax)
timeFrame: 0-70days
measure: Plasma clearance(CL)
timeFrame: 0-70days
Secondary outcomes:
measure: Anti-drug antibodies(ADA)
timeFrame: 0-70days
measure: Best correct vision(BCVA)
timeFrame: 0-70days
measure: Central Retinal thickness(CRT)
timeFrame: 0-70days
measure: VEGF concentration
timeFrame: 0-70days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Peking Union Medical College
name: Youxin Chen
role: PRINCIPAL_INVESTIGATOR
References: