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

NCT04667039 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

  • Age Related Macular Degeneration (ARMD)

Interventions

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)

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana Markova, MD · AO GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-20
Primary Completion
2024-08-15
Completion
2024-09-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667039 on ClinicalTrials.gov