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A Study to Compare GNR-139 and Eylea® in Patients With nAMD

RecruitingPhase 3Ages 50 Years - anyAllAO GENERIUM
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, randomized, double-blind study designed to compare the efficacy and safety of the investigational drug GNR-139 with the reference drug Eylea in treatment-naive patients with neovascular age-related macular degeneration (nAMD). Participants will be randomly assigned to receive either GNR-139 or Eylea. Neither the participants nor the study doctors will know which treatment is being administered. Both drugs will be given as an intravitreal injection dose of 8 mg (0.07 mL at a concentration of 114.3 mg/mL). Patients meeting the eligibility criteria will be randomised in a 2:1 ratio into one of two treatment groups: * Group I (GNR-139): 120 patients; * Group II (Eylea®): 60 patients. The main goal of the study is to evaluate if GNR-139 has similar efficacy to Eylea. This will be determined by measuring the change in the Best-Corrected Visual Acuity (BCVA) score at W

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📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Men and women aged ≥ 50 years at the time of signing the Informed Consent Form. 2\. Written informed consent obtained from the patient or, in the case of severe visual impairment in the patient, with the participation of an impartial witness, prior to the initiation of any study-related procedures. 3\. Willingness of a patient of childbearing potential to adhere to adequate methods of contraception throughout the study (from the signing of the Informed Consent Form) and for at least 120 days after the last IVI of aflibercept. 4\. Patient's willingness and ability to adhere to the schedule of visits and perform the procedures required by the protocol. Ophthalmic inclusion criteria: Study eye 5. Previously untreated active MNV secondary to nAMD (i.e., presence of FFA leakage, as well as IRF and/or SRF and/or subretinal hyperreflective material and/or serous or fibrovascular RPE detachment based on OCT data) meeting the following criteria: 5.1. Any subtype of secondary MNV (classic, occult, predominantly classic or minimally classic, with a classic component, retinal angiomatous proliferation, and polypoidal choroidal vasculopathy); 5.2. Sub foveal or juxta foveal location, but with a sub foveal component related to MNV activity (e.g., IRF or SRF detected by OCT, or RPE detachment); 5.3. Total lesion area (including hemorrhage, scarring, and neovascularization) ≤ 12 disc areas (DA) based on FFA data; 5.4. Total MNV area must comprise ≥ 50 % of the total lesion area based on FFA results, including all subtypes of neovascular AMD (nAMD); 5.5. Presence of IRF and/or SRF involving the central sub foveal zone (1 mm diameter), or presence of sub retinal hyperreflective material or neovascular RPE detachment in this zone based on OCT data. 6\. BCVA score between 74 and 24 letters (inclusive) on the ETDRS chart at screening and prior to randomization on Day 1 (before pupil dilation). 7\. CST at screening ≥ 300 µm based on OCT data. Exclusion Criteria: * 1\. Known hypersensitivity to aflibercept or to any of the excipients contained in GNR-139 or Eylea®. 2\. Known hypersensitivity to sodium fluorescein for injection used for FFA. 3. Uncontrolled arterial hypertension at screening: systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg. 4\. Traumatic brain injury, transient ischemic attack, or stroke within 180 days prior to randomization. 5\. Unstable angina, myocardial infarction, clinically significant arrhythmia (e.g., atrial fibrillation Class III-IV according to the modified European Heart Rhythm Association (EHRA) scale), or congestive heart failure Class III or IV according to the New York Heart Association (NYHA) classification within 180 days prior to randomization. 6\. History or current malignancy (except for adequately treated basal cell carcinoma, cervical carcinoma in situ, or any malignancy with complete remission for at least 5 years). 7\. History of a medical condition or any disease (somatic, neurological, and/or psychiatric) that, in the opinion of the investigator, is a contraindication to the administration of the investigational or reference medicinal product, or may contribute to the misinterpretation of study results, or places the patient at high risk of developing complications during treatment (e.g., history of organ transplantation, immunocompromised status, etc.) and/or may interfere with the scheduled study visits. 8\. Blood or blood component transfusion within 10 days prior to signing the Informed Consent Form and/or at Screening. 9\. History of tuberculosis (within 3 years prior to signing the informed consent form) and/or at screening; history of alcoholism, drug dependence, or substance abuse. 10\. Acute hepatitis or liver cirrhosis of any etiology. 11. Positive test results for HIV, hepatitis B and/or C. 12. Participation in any clinical studies and/or use of an investigational medicinal product within 90 days prior to signing the Informed Consent Form. 13\. History of systemic anti-angiogenic therapy (e.g., use of anti-angiopoietin, bevacizumab, aflibercept, ranibizumab, pegaptanib, cetuximab, panitumumab, etc.). 14\. Systemic use of glucocorticosteroids within 180 days prior to randomization (more than 10 mg of prednisone equivalent received daily). 15\. Pregnancy or breast-feeding. Ophthalmic criteria: Study eye: 16\. Causes of MNV other than nAMD (e.g., ocular histoplasmosis, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia, post-traumatic MNV, etc.). 17\. Irreversible structural damage involving the foveal zone (e.g., subretinal fibrosis or atrophy comprising \> 50 % of the total lesion area, or macular ischemia). 18\. RPE tear involving the center of the macula. 19. Sub- or intraretinal hemorrhage comprising ≥ 50 % of the total lesion area, or subfoveal hemorrhage with a size ≥ 1 disc area (DA). 20\. Uncontrolled glaucoma likely to progress during the study, or glaucoma with uncompensated IOP during therapy (IOP ≥ 25 mmHg despite treatment with anti-glaucoma medications). 21\. Any concomitant macular disorder other than AMD that, in the opinion of the investigator, may affect central vision or the efficacy of the treatment administered, including severe epiretinal fibrosis with a significant tractional component, macular telangiectasia, etc. 22\. History of Stage 2 or higher macular holes. 23. Aphakia or pseudophakia with absence of the posterior lens capsule (except for cases of YAG capsulotomy performed more than 30 days prior to signing the Informed Consent Form). 24\. Myopia with a spherical equivalent ≥ 8 diopters prior to any surgical intervention. 25\. Significant opacities of the optical media (including cataract) interfering with BCVA assessment, fundus photography, or OCT. 26\. Any concomitant intraocular disease of the study eye (e.g., glaucoma, cataract, or diabetic retinopathy) that, in the opinion of
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What it tests

  • aflibercept
  • Eylea
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Where

14 sites
Cheboksary branch of S. Fyodorov Eye Microsurgery Federal State Institution
Cheboksary, Russia
Medical organization "Optic-Center" Ltd
Chelyabinsk, Russia
Sverdlovsk Regional Clinical Hospital No.1
Yekaterinburg, Russia
Ivanovo regional clinical hospital
Ivanovo, Russia
Federal State Budgetary Institution "Helmholtz National Medical Research Center of Eye Diseases" of the Ministry of Health of the Russian Federation
Moscow, Russia
Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine"
Moscow, Russia
S.Fyodorov Eye Microsurgery Federal State Institution
Moscow, Russia
Volga District Medical Center of the Federal Medical and Biological Agency
Nizhny Novgorod, Russia

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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