The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD)

  • STATUS
    Recruiting
  • days left to enroll
    49
  • participants needed
    67
  • sponsor
    Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Updated on 25 January 2021

Summary

Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody

Description

According to the results of preclinical pharmacological research and clinical application of bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the treatment of ocular diseases such as wAMD .Observe the safety and tolerability of the single and multiple doses of 601 in wAMD patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with wAMD.

Details
Condition Wet Age Related Macular Degeneration
Treatment Drug 601
Clinical Study IdentifierNCT04468997
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sign informed consent form and willing to be visited at the time specified in the trial
Age 45 years and age 80 years
The study eye must meet the following criteria
Diagnosis of wAMD
The presence of an primary or recurrent active choroidal neovascular (CNV) lesions in subfovea and para-fovea secondary to AMD
Total area of all types of lesions 30mm2 (12 optic disc areas)
Best EDTRS letter score between 19 and 78(Snellen equivalent of 20/400 to 20/32)
No optometric media opacity and pupil shrinkage
Best EDTRS letter score 19 (Snellen equivalent of 20/400 or better) in the fellow eyes

Exclusion Criteria

Any of the following eye conditions
Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis, conjunctivitis)
History of vitreous hemorrhage in the study eye within 2 months before screening
scarring, fibrosis, or atrophy below with fovea in the study eye
Received any drug treatment for CNV within 120 days prior to screening
History of any following surgery in the study eye (e.g. PDT, macular transposition, Glaucoma filtration, subfoveal photocoagulation, vitrectomy and transpupular hyperthermia, and other surgery at the submacular or others for AMD) within 3 months before screening
CNV in the study eye associated with other ocular diseases such as pathologic myopia, eye trauma, etc
History or present of uncontrolled glaucoma, history of glaucoma filtering surgery in the study eye
Subretinal hemorrhage in the study eye, and the bleeding area 50% area of the total lesion
History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage 3 or 4) , retinal detachment, retinal pigment epithelium tear or macular area traction and macular area preretinal membrane and PCV in the study eye
The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens
Any of the following general condition are present
\. Medicines with toxicity to the lens are being used or may be used during
the study period
\. History of allergy to fluorescein sodium and allergies to protein
products for treatment or diagnosis, history of allergy to more than two drugs
and/or non-drug factors, or suffering from allergic diseases now
\. History of surgery within 1 months before screening; and/or unhealed
wounds, ulcers or fractures currently
\. Suffering from systemic infections and requiring oral, intramuscular or
intravenous medication
\. History of stroke, myocardial infarction within 6 months before
screening
\. Active diffuse intravascular coagulation and obvious bleeding tendency
within 3 months before screening
\. Systemic immune diseases
\. Uncontrolled blood pressure control
\. Diabetic patients with uncontrolled blood sugar
\. Any uncontrolled clinical problems (such as severe mental, neurological
cardiovascular, respiratory and other systemic diseases and malignant
tumours)
Any of the following laboratory tests abnormalities(23-25)
\. Renal function impairment (Cr is 1.5 times higher than the upper limit of
normal values in the local laboratory) Liver dysfunction (ALT or AST is 2
times higher than the upper limit of normal value in the local laboratory)
\. Abnormal coagulation function (prothrombin time >= the upper limit of
normal value for 3 seconds) and activated partial thromboplastin time >= the
upper limit of normal value for 10 seconds)
Patients with childbearing age with any of the following conditions
\. Those who do not use effective contraceptive measures
The following are not excluded
\. Pregnancy and lactation women (pregnancy is defined as urinary pregnancy
test positive in this study)
Any other conditions
\. Participation in any other drug clinical trials (except vitamins and
minerals) in the past 1 month before screening
\. Researchers think it needs to be ruled out
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