Age Related Macular Degeneration (ARMD)Phase 3NAPNCT04667039
Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis®
A Phase 3 study testing GNR-067 and Lucentis® in people with Age Related Macular Degeneration (ARMD), run by AO GENERIUM at 9 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration (ARMD)
- What is being tested?
- GNR-067 and Lucentis®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 9 sitesRussia
- Study dates
- 20 Mar 2022to 15 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Ophthalmic inclusion criteria (must be present in one eye, which will be considered the examined eye)
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 27Show fewer
- 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;
- Vaccination (any vaccine) within 30 days prior to the Screening Visit and/or the need for vaccination during the study period;
- Systemic treatment with corticosteroids (more than 10 mg of prednisolone equivalent) within 6 months prior to the Screening Visit;
- Use of systemic medicinal products known to be toxic for the eye lens, retina, or optic nerve during the study.
- Medical history of a clinically significant pathology identified during the screening period including, but not limited to:
- Unstable angina pectoris, myocardial infarction, arrhythmia requiring drug therapy, Class III or IV congestive heart failure according to the New York Heart Association classification within one year before the Screening Visit; Brain injury, stroke, or transient ischemic attack within one year prior to the Screening Visit; Severe renal failure (estimated glomerular filtration rate according to the CKD-EPI formula <40 mL/min/1.73 m2); Severe hepatic impairment (serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) activity of 2.5 or more times higher than the laboratory upper limit of normal (ULN), and/or the level of total bilirubin of 1.5 or more times higher than the laboratory ULN);
- Variation of peripheral blood parameters:
- Leukocytes: <3.8 × 109/L Platelets: <100 × 109 cells/L Hemoglobin: ≥10.0 g/dL
- Pregnancy and breastfeeding;
- Patients who received blood or blood component transfusions within 10 days prior to the Screening Visit;
- History (within three years prior to the Screening Visit) of tuberculosis, alcoholism, narcotic, drug dependence and/or substance abuse, or presence of the above at the Screening stage;
- Acute hepatitis or liver cirrhosis of any etiology; antibodies to hepatitis C or HBsAg at the Screening Visit; acquired immune deficiency syndrome or infection with human immunodeficiency virus (HIV) confirmed by test results;
- Participation of the patient in any clinical studies and/or use of experimental medicinal products within 3 months prior to the Screening Visit.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites, 9 recruiting
- Not yet recruiting
Regional budgetary healthcare institution "Ivanovo Regional Clinical Hospital"
Ivanovo, Ivanovo Oblast, 152040
- Not yet recruiting
State Autonomous Healthcare Institution "Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan" Kazan
Kazan', Tatarstan Republic, 420012
- Not yet recruiting
Limited Liability Company "Kuzlyar"
Kazan', Tatarstan Republic, 420066
- 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
- Not yet 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
- 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
- Recruiting
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, Novosibirsk Oblast, 630000
- Recruiting
State Budgetary Healthcare Institution of the Omsk region "Clinical ophthalmological hospital named after V.P. Vykhodtseva"
Omsk, Omsk Oblast, 644024
- 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
About this study
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
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.
Read the 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)
- Being tested
- GNR-067, Lucentis®
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-067Biological
Also called Ranibizumab
GNR-067 will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)
Lucentis®Biological
Also called Ranibizumab
Lucentis® will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL)
| Study group | Role | What they receive |
|---|---|---|
| GNR-067 | Experimental | Ranibizumab Receives: Biological: Lucentis® |
| Lucentis® | Active comparator | Ranibizumab Receives: Biological: GNR-067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
The best-corrected visual acuity (BCVA) score on the ETDRS chart (measured using logMAR/Snellen chart) of 15 or fewer 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.
Measured: 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.
The decrease of the central retinal thickness (CRT) in patient with neovascular (wet) age-related macular are standard of the optical coherence tomography (OCT).
Measured: 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.
The presence (incomplete recovery) of intraretinal fluid and subretinal fluid in patient with neovascular (wet) age-related macular are standard for fluorescent angiography.
Measured: 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.
NEI VFQ-25 medical ophthalmological questionnaire is standard of the assessment changes in visual acuity and quality of life of patients with neovascular (wet) age-related macular.
Measured: At Week 24 Week 52 versus baseline in the compared groups.
Immunogenicity
The frequency of antidrug antibodies formation.
Measured: The frequency of formation of ADAs to ranibizumab at Day 1, Day 8, Week 8, Week 24, Week 36, and Week 52 of treatment with the investigational or reference product with the characterization of antibodies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start20 Mar 2022
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana Markova, MD, Study chair, AO GENERIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667039
- Sponsor's protocol ID
- RBS-AMD-III
- Acronym
- NAP
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NAP
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04667039
- Acronym / sponsor ID
- NAP / RBS-AMD-III
- Conditions
- Age Related Macular Degeneration (ARMD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| GNR-067 | Experimental | Biological: Lucentis®Ranibizumab |
| Lucentis® | Active comparator | Biological: GNR-067Ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Ophthalmic inclusion criteria (must be present in one eye, which will be considered the examined eye)
- 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;
Key exclusion criteria (27 listed)
- 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.:
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNR-067Also: RanibizumabGNR-067 will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL) | Biological | Lucentis® |
| Lucentis®Also: RanibizumabLucentis® will be used intravitreally once every 4 weeks in 0.5 mg doses (the injection volume is 0.05 mL) | Biological | GNR-067 |
Primary outcome
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.
Time frame: At 8 Week after comparative treatment beginning (GNR-067 vs. Lucentis®).
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.
6 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 24 Week 52 versus baseline in the compared groups.
Immunogenicity
Time frame: The frequency of formation of ADAs to ranibizumab at Day 1, Day 8, Week 8, Week 24, Week 36, and Week 52 of treatment with the investigational or reference product with the characterization of antibodies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No. NAP
Related trials for Age Related Macular Degeneration (ARMD)
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana Markova, MD study chair
AO GENERIUM
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GNR-067 and Lucentis® in people with Age Related Macular Degeneration (ARMD), run by AO GENERIUM at 9 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Zozulya, SD (+7-925-400-01-26, ovzozulya@generium.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At 8 Week after comparative treatment beginning (GNR-067 vs. Lucentis®).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.