Phase I Study to Compare CMAB818 Injection and Lucentis in Patients With Wet AMD

  • STATUS
    Recruiting
  • End date
    Jul 18, 2022
  • participants needed
    24
  • sponsor
    Shanghai Biomabs Pharmaceutical Co., Ltd.
Updated on 18 June 2021

Summary

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis in patients with wet age-related macular degeneration.

Description

This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four sites. Subjects will be sequentially enrolled according to the protocol in one of two cohorts and receive a single 0.5mg of CMAB818 or Lucentis through intravitreal injection.

The primary objective is to assess the initial clinical safety of intravitreal injection of CMAB818 or Lucentis in patients with wet age-related macular degeneration (wet-AMD).

The secondary objective are to assess immnogenicity, pharmacokinetic, pharmacodynamics and the initial clinical efficacy of intravitreal injection of CMAB818 or Lucentis in patients with wet age-related macular degeneration (wet-AMD).

Details
Condition Wet Age Related Macular Degeneration
Treatment CMAB818, Lucentis®
Clinical Study IdentifierNCT04884399
SponsorShanghai Biomabs Pharmaceutical Co., Ltd.
Last Modified on18 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sign the informed consent, and able to receive follow-up according to the time stipulated by the trial
50 yearsage80 years, male or female
The target eye must meet the following requirements: newly occurring or relapsed subfoveal and perifoveal active choroidal neovascularization (CNV) lesions secondary to AMD; the best corrected visual acuity between 78-19 letters (including the boundary value, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, equivalent to Snellen visual acuity of 20/32 to 20/400); no refractive media opacity or myosis affecting fundus examination
The best corrected visual acuity of the subject's non-target eye19 letters (using ETDRS charts, equivalent to Snellen visual acuity of 20/400)

Exclusion Criteria

Previously received anti-VEGF drug treatment in either eye within 3 months before screening (e.g., aflibercept<Eylea>, ranibizumab<Lucentis>, bevacizumab<Avastin>, Conbercept<Lumitin>, etc.)
Active eye infection in either eye within 1 months before screening (including but not limited to Blepharitis, Conjunctivitis infective, Keratitis, Scleritis, Endophthalmitis)
History of vitreous hemorrhage within 3 months before screening
History or presence of uncontrolled glaucoma (defined as intraocular pressure(IOP)>25 mmHg despite treatment with maximal medical therapy),or the optic fovea/optical disc ratio of the target eye caused by severe glaucoma > 0.8
Previously received subconjunctival/intravitreal corticosteroids injection within 3 months (including subconjunctival/intravitreal long-acting implants within 6 months), or local ocular corticosteroids treatment in the target eye within 1 month before screening
Previously received the following ophthalmic surgery such as verteporfin photodynamic therapy (PDT), macular translocation, glaucoma filtering, subfoveal laser photocoagulation, vitrectomy and transpupillary thermotherapy, and other submacular surgery or surgery used to treat age-related macular degeneration in the target eye
Other ocular diseases other than wAMD that affect the central vision, such as dry AMD, venous occlusion, uveitis, diabetic retinopathy, vascular-like streaks, pathological myopia, retinal detachment, macular hole, etc. in the target eye
Aphakia (excluding intraocular lenses) or rupture of the posterior lens capsule in the target eye [except for yttrium aluminum garnet (YAG) laser posterior capsulotomy after intraocular lens implantation]
History of rhegmatogenous retinal detachment or macular hole retinal detachment (stage 3 or 4), with retinal detachment, retinal pigment epithelial tear, or retinal traction in the macular area and epiretinal disease in the macular area in the target eye
Current use or may need to use systemic drugs that can cause crystal toxicity, such as psoralen, risedronate sodium, tamoxifen, etc
Allergy to fluorescein sodium or indocyanine green, protein products for treatment or diagnosis, and more than 2 drugs and/or non-drugs
History of surgical operations (except for minimally invasive surgery that has healed) or currently unhealed wounds, moderate to severe ulcers, fractures, etc. within 1 month before screening
Presence of infectious diseases that require oral, intramuscular or intravenous administration
Presence of active diffuse intravascular coagulation or obvious bleeding tendency or abnormal coagulation function before screening (prothrombin time 3 seconds of upper limit of normal value, activated partial thromboplastin time 10 seconds of upper limit of normal value)
History of myocardial infarction, cerebral infarction, unstable angina, coronary revascularization, New York College of Cardiology (NYHA) grade grade II cardiac insufficiency, severely unstable ventricular arrhythmia, and cerebrovascular accident (including transient ischemic attack) before screening
Presence of systemic immune diseases (including but not limited to systemic lupus erythematosus, immune hemolytic anemia, hyperthyroidism)
Uncontrolled hypertension(defined assystolic blood pressure160 mmHg and/or diastolic blood pressure100 mmHg diastolic despite treatment with antihypertensive drugs
Diabetes with uncontrolled blood glucose (defined as fasting blood glucose7.0 mmol/L)
Any uncontrollable clinical problems (including but not limited to serious mental, neurological, respiratory and other system diseases, as well as malignant tumors)
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 1.5 times the laboratory upper limit of normal (ULN) and/or blood creatinine is higher than ULN and the investigator judges that the abnormality has clinical significance
Concurrent with hepatitis B (positive hepatitis B virus surface antigen), hepatitis C (positive hepatitis C virus antibody), AIDS (positive human immunodeficiency virus antibody) or syphilis (positive syphilis antibody)
Pregnant and lactating women
Refuse to take effective contraceptive measures during childbearing age throughout the study period
Participated in any drug (excluding vitamins and minerals) and medical device clinical trials within 3 months before screening (if the drug has a long half-life and its 5 half-life time is greater than 3 months, then choose the 5 half-life time)
Any other situations that investigator thinks the subject is inappropriate to participate in this study
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