Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667039
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2020-11-30
Brief Title:
Efficacy Safety pharmacokinetiŃs Immunogenicity of GNR-067 and Lucentis
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAP
Brief 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 andor subretinal under the neurosensory retina or pigment epithelium fluid extravasal dye exit from the newly formed vessels and the presence of a subfoveal andor 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 21 ratio investigationalreference 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 05 mg doses the injection volume is 005 mL
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 andor subretinal under the neurosensory retina or pigment epithelium fluid extravasal dye exit from the newly formed vessels and the presence of a subfoveal andor 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 21 ratio investigationalreference 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 05 mg doses the injection volume is 005 mL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None