NCT04667039

Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis®

International, Multicenter, Randomized, Double-blind, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GNR-067 and Lucentis® in Patients With Neovascular (Wet) Age-related Macular Degeneration

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, comparative, parallel group study of the efficacy, safety pharmacokinetics, and immunogenicity of GNR-067 and Lucentis® in patients with neovascular (wet) age-related macular degeneration.

Detailed description

Age-related macular degeneration (ARMD) is a chronic progressive disease that is the main cause of visual disability in elderly patients (aged over 60 years) in industrialized countries. Due to increased human longevity, it is expected for the number of patients with this disease to grow worldwide up to 288 million people by 2040. The highest risk of vision loss is posed by neovascular (exudative or wet ARMD) macular degeneration observed in 10-20% of cases. The pathological changes of ARMD are based on the increased production of the vascular endothelial growth factor (VEGF) which affects proprioceptors located on the surface of endothelial cells and causes an anomalous permeability of vessels and stimulates neovascularization GNR-067 (JSC "GENERIUM", the Russian Federation) is a humanized recombinant monoclonal antibody selectively binding to the human vascular endothelial growth factor \[VEGF-A\] and is a biosimilar of of the original product Lucentis® ("Novartis Pharma AG", Switzerland). This III phase study is aimed to compare the effectiveness, safety, pharmacokinetics and immunogenicity of GNR-067 (JSC "GENERIUM", the Russian Federation) and Lucentis® ("Novartis Pharma AG", Switzerland) in order to register of the drug GNR-067 (JSC "GENERIUM", the Russian Federation), a solution for intraocular injection administration, in the Russian Federation. The study included patients (n = 408) aged 50 years and older with neovascular (wet) age-related macular degeneration, types 1 and 2 (occult and classical) choroidal neovascularization (CNV) with the following activity signs: accumulation of intraretinal and/or subretinal (under the neurosensory retina or pigment epithelium) fluid, extravasal dye exit from the newly formed vessels, and the presence of a subfoveal and/or juxtafoveal membrane and the presence of CNV foci of more than 50% of the total lesion area. With block randomization, the patients were divided into two groups in a 2:1 ratio (investigational/reference product): 272 patients to the group of the investigational product GNR-067 and 136 patients to the group of the reference product Lucentis®. The duration of the study for each patient will be approximately 52 ± 4 weeks, including a screening period (3 weeks), treatment period and a follow-up period (4 weeks). In this study GNR-067 and Lucentis® will be used intravitreally once every 4 weeks (thirteen injections in total) in 0.5 mg doses (the injection volume is 0.05 mL).

Conditions

• Age Related Macular Degeneration (ARMD)

Interventions

Type	Name	Description
BIOLOGICAL	GNR-067	GNR-067 will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)
BIOLOGICAL	Lucentis®	Lucentis® will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)

Timeline

• Start date: 2022-03-20
• Primary completion: 2024-08-15
• Completion: 2024-09-15
• First posted: 2020-12-14
• Last updated: 2023-09-13

Locations

9 sites across 1 country: Russia