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

NCT04884399 | Completed Phase 1

• 1 other identifier: CMAB818-I-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events That Are Related to Treatment

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant graded according to the common terminology criteria for adverse events (CTCAE) v.5.0 criteria, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs

  0~42 days

Secondary Outcomes (11)

• Number of Participants With anti-drug antibody

  0~42 days

• Percentage of neutralizing antibody

  0~42 days

• AUC(0-t)

  0~42 days

• Cmax

  0~42 days

• CL

  0~42 days

Study Arms (2)

CMAB818

EXPERIMENTAL

0.5 mg by intravitreal injection once on the first day.

Drug: CMAB818

Lucentis®

ACTIVE COMPARATOR

0.5 mg by intravitreal injection once on the first day.

Drug: Lucentis®

Interventions

CMAB818 DRUG

vascular endothelial growth factor (VEGF) inhibitor

Also known as: Ranibizumab Injection

CMAB818

Lucentis® DRUG

vascular endothelial growth factor (VEGF) inhibitor

Also known as: Ranibizumab Injection

Lucentis®

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent, and able to receive follow-up according to the time stipulated by the trial;
• years≤age≤80 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 eye≥19 letters (using ETDRS charts, equivalent to Snellen visual acuity of 20/400).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Biomabs Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Peking University People'S Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wenbin Wei, PhD

  Beijing Tongren Hospital

  STUDY CHAIR

• Xiuli Zhao, PhD

  Beijing Tongren Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 13, 2021
• Study Start: June 3, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (4)