A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:

A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151212
• Other study ID #: BAT5906-001-CR
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2019
• Source: Bio-Thera Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• BAT5906 injection
Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity(DLT)	Safety and tolerability endpoint	2 weeks
Primary	Maximum tolerated dosed(MTD)	Safety and tolerability endpoint	0-70days
Primary	Area under the curve(AUC0-t, AUC0-inf)	Pharmacokinetic endpoint Pharmacokinetic endpoint	0-70days
Primary	Maximum serum drug concentration(Cmax)	Pharmacokinetic endpoint Pharmacokinetic endpoint	0-70days
Primary	Half-life period(t1/2)	Pharmacokinetic endpoint	0-70days
Primary	Maximum serum drug time(Tmax)	Pharmacokinetic endpoint	0-70days
Primary	Plasma clearance(CL)	Pharmacokinetic endpoint	0-70days
Secondary	Anti-drug antibodies(ADA)	Immunogenic endpoint	0-70days
Secondary	Best correct vision(BCVA)	Effective endpoint	0-70days
Secondary	Central Retinal thickness(CRT)	Effective endpoint	0-70days
Secondary	VEGF concentration	Pharmacodynamics endpoint	0-70days