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

NCT04667039 | Unknown Phase 3

• 1 other identifier: RBS-AMD-III
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 9

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.

Conditions

Age Related Macular Degeneration (ARMD)

Outcome Measures

Primary Outcomes (1)

• The proportion of patients (%) with an increase in the best-corrected visual acuity (BCVA) score on the ETDRS chart (measured using logMAR/Snellen chart) of 15 or more letters at Week 8 versus baseline in the compared groups.

  Global evaluation of treatment effectiveness (the best-corrected visual acuity (BCVA) score on the ETDRS chart (measured using logMAR/Snellen chart)) of 15 or more letters are a validated tool and has been used to evaluate the clinical response to ranibizumab in patients with with neovascular (wet) age-related macular degeneration.

  At 8 Week after comparative treatment beginning (GNR-067 vs. Lucentis®).

Secondary Outcomes (6)

• The proportion of patients (%) with an increase in the best-corrected visual acuity (BCVA) score on the ETDRS chart (measured using logMAR/Snellen chart) of 15 or more letters at Week 24, Week 52 versus baseline in the compared groups.

  At Week 24, Week 52 after comparative treatment start (GNR-067 vs. Lucentis®) and compared to baseline.

• The proportion of patients (%) with a decrease in the best-corrected visual acuity (BCVA) score on the ETDRS chart (measured using logMAR/Snellen chart) of 15 or fewer letters at Week 8, Week 24, and Week 52 versus baseline in the compared groups.

  At Week 8, Week 24, Week 52 weeks after comparative treatment start (GNR-067 vs. Lucentis®) and compared to baseline.

• The decrease of the central retinal thickness (CRT) measured with optical coherence tomography in the spectral range at Week 8, Week 24, Week 52 versus baseline in the compared groups.

  At Week 8, Week 24, Week 52 versus baseline in the compared groups.

• The proportion of patients (%) with the presence (incomplete recovery) of intraretinal fluid and subretinal fluid at Week 8, Week 24, Week 52 versus baseline in the compared groups.

  At Week 8, Week 24, Week 52 versus baseline in the compared groups

• The assessment of changes in visual acuity and quality of life of patients by the questionnaire method using the NEI VFQ-25 medical ophthalmological questionnaire at Week 24 Week 52 versus baseline in the compared groups.

  At Week 24 Week 52 versus baseline in the compared groups.

Study Arms (2)

GNR-067

EXPERIMENTAL

Ranibizumab

Biological: Lucentis®

Lucentis®

ACTIVE COMPARATOR

Ranibizumab

Biological: GNR-067

Interventions

GNR-067 BIOLOGICAL

GNR-067 will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)

Also known as: Ranibizumab

Lucentis®

Lucentis® BIOLOGICAL

Lucentis® will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)

Also known as: Ranibizumab

GNR-067

Eligibility Criteria

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

You may qualify if:

• Men and women aged 50 years and older;
• The signed informed consent obtained from the patient, or, in cases of severe visual impairment in the patient, with the participation of an impartial witness, prior to any study-related procedures.
• The previously diagnosed neovascular (wet) age-related macular degeneration confirmed at the Screening Visit:
• untreated, except for food supplement, vitamins, mineral additives (one examined eye in one patient); 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;
• The best-corrected visual acuity within a range from 34 to 83 letters (20/200 to 20/25) measured using the ETDRS chart Early Treatment Diabetic Retinopathy Study Research Group protocol (chart at a distance of 4 m) before pupil dilation;
• The willingness and ability of the patient to perform all planned study visits and procedures (according to the Investigator);
• IOP ≤21 mmHg (actual);
• An ECG within normal values or clinically insignificant findings.

You may not qualify if:

• Medical history of CNV treatment with intravitreal injections of VEGF inhibitors (ranibizumab, bevacizumab, aflibercept, or pegaptanib, etc.), or any other investigational poducts into the examined eye;
• Medical history of subretinal laser photocoagulation or other surgical interventions for ARMD in any eye;
• Preexisting and current lesions, diseases, or interventions in the eyes.:
• In the examined eye:
• Keratoplasty or corneal dystrophy Capsulotomy performed 4 weeks prior to screening Aphakia, vitrectomy Presence of a macular hole at any stage Past rhegmatogenous retinal detachment Any other past intraocular surgical interventions in the examined eye (including cataract extraction in the examined eye) within 3 months prior to the Screening Visit
• In any eye:
• Choroidal neovascularization in any eye due to reasons not related to ARMD (for example, multifocal choroiditis, ocular histoplasmosis syndrome, injury, etc.) Past idiopathic or autoimmune uveitis in any eye Scleromalacia Diagnosed diabetic retinopathy
• Current conditions and diseases identified at the screening stage:
• High degree myopia (over 8 diopters) in any eye; Presence of progressive glaucoma (intraocular pressure ≥21 mmHg against performed antihypertensive glaucoma therapy) or optic neuropathy that affect or endanger the central field of view in the examined eye at the screening stage; Subretinal hemorrhage and/or hemorrhage in the retinal tissue occupying ≥50% of the total affected area in the examined eye; Presence of a rupture (solution of continuity) of the retinal pigment epithelium (RPE) also extending to the macula in any eye; A scar or subretinal fibrosis in the macular area occupying more than 50% of the total affected area in any eye; Presence of vitreomacular traction or epiretinal membrane significantly affecting central vision; Other than ARMD progressive retinal diseases in the examined or fellow eye that may complicate the assessment of visual acuity; The total size of the lesion is more than 12 disc areas (DA: 30.5 mm2 including areas occupied by blood, neovascularization, or fibrosis), based on a FAG performed at screening; Confirmed or assumed (within 28 days prior to the Screening Visit) intraocular, extraocular, and periocular inflammation or infection in any eye.
• Any intravitreal injections of corticosteroids (e.g., triamcinolone acetonide) for ≥30 days in a row in the examined eye 90 days prior to the Screening Visit and/or injection of an intravitreal corticosteroid implant with a gradual release of the medicinal product into the examined eye within 180 days prior to the Screening Visit;
• Known allergic reactions and/or hypersensitivity to Lucentis® (ranibizumab) or any ingredients of GNR-067;
• Known allergic reactions and/or hypersensitivity to fluorescein sodium (for injections);
• Uncontrolled arterial hypertension (BP ≥180/90 mmHg);
• Diseases of the immune and endocrine system, not controlled by drug therapy (including decompensated diabetes mellitus and thyroid diseases);
• Medical history or current (active cancer)of oncological diseases with the exception of cured basal cell carcinoma;

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (9)

Regional budgetary healthcare institution "Ivanovo Regional Clinical Hospital"

Ivanovo, Ivanovo Oblast, 152040, Russia

NOT YET RECRUITING

State Budgetary Healthcare Facility of the St. Petersburg Region "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation

Saint Petersburg, Leningradskaya Oblast', 197022, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry named after A.I. Evdokimov "of the Ministry of Health of the Russian Federation

Moscow, Moscow Oblast, 127473, Russia

NOT YET RECRUITING

Federal State Autonomous Institution "Interbranch Scientific and Technical Complex" Eye Microsurgery "named after academician S.N. Fedorov "of the Ministry of Health of the Russian Federation

Moscow, Moscow Oblast, 127486, Russia

NOT YET RECRUITING

State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

Novosibirsk, Novosibirsk Oblast, 630000, Russia

RECRUITING

State Budgetary Healthcare Institution of the Omsk region "Clinical ophthalmological hospital named after V.P. Vykhodtseva"

Omsk, Omsk Oblast, 644024, Russia

RECRUITING

State Autonomous Healthcare Institution "Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan" Kazan

Kazan', Tatarstan Republic, 420012, Russia

NOT YET RECRUITING

Limited Liability Company "Kuzlyar"

Kazan', Tatarstan Republic, 420066, Russia

NOT YET RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation

Kazan', Tatarstan Republic, 443099, Russia

NOT YET RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Oksana Markova, MD

  AO GENERIUM

  STUDY CHAIR

Central Study Contacts

Olga Zozulya, SD

CONTACT

+7-925-400-01-26; ovzozulya@generium.ru

Oksana Markova, MD

CONTACT

7-985-441-89-59; oamarkova@generium.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Throughout the study, until the end of the comparative treatment study period, neither the investigators nor the patients knew which drug was being administered
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 14, 2020
• Study Start: March 20, 2022
• Primary Completion: August 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (9)