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

NCT07844148 | Recruiting Phase 3

• 1 other identifier: GNR139-AMD03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 14

Brief Summary

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 Week 8 in participants who completed the treatment.

Conditions

nAMD

Keywords

Neovascular Age-Related Macular Degeneration; nAMD; GNR-139; Biosimilar; High-Dose Aflibercept

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BCVA, assessed by the number of letters read correctly on the ETDRS chart, at Week 8.

  This endpoint will be used to evaluate the therapeutic equivalence of GNR-139 and Eylea® in terms of functional ophthalmic outcome

  Week 8

Secondary Outcomes (13)

• Change from baseline* in BCVA, assessed by the number of letters read correctly on the ETDRS chart, at Weeks 4, 12, 16, 20, 24, 40, and 56

  Weeks 4, 12, 16, 20, 24, 40, and 56

• Change from baseline in CST based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56

  Weeks 4, 8, 12, 16, 20, 24, 40, and 56

• Proportion of patients with absence of IRF and SRF in the MNV zone based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline

  Weeks 4, 8, 12, 16, 20, 24, 40, and 56

• Proportion of patients with a reduction in IRF and SRF in the MNV zone based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline

  Weeks 4, 8, 12, 16, 20, 24, 40, and 56

• Proportion of patients with absence of RPE detachment (both serous and fibrovascular) based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline

  Weeks 4, 8, 12, 16, 20, 24, 40, and 56

Study Arms (2)

Group I (GNR-139): 120 patients

EXPERIMENTAL

GNR-139 is being developed as a biosimilar to the reference medicinal product Eylea®

Biological: aflibercept

Group II (Eylea®): 60 patients

ACTIVE COMPARATOR

Biological: Eylea

Interventions

aflibercept BIOLOGICAL

GNR-139 is being developed as a biosimilar to the reference medicinal product Eylea®

Group I (GNR-139): 120 patients

Eylea BIOLOGICAL

Eylea® (INN: aflibercept), 114.3 mg/mL, solution for intravitreal injection

Group II (Eylea®): 60 patients

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 at the time of signing the Informed Consent Form.
• \. 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.
• \. 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.
• \. Patient's willingness and ability to adhere to the schedule of visits and perform the procedures required by the protocol.
• 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.
• \. BCVA score between 74 and 24 letters (inclusive) on the ETDRS chart at screening and prior to randomization on Day 1 (before pupil dilation).
• \. CST at screening ≥ 300 µm based on OCT data.

You may not qualify if:

• \. Known hypersensitivity to aflibercept or to any of the excipients contained in GNR-139 or Eylea®.
• \. 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.
• \. Traumatic brain injury, transient ischemic attack, or stroke within 180 days prior to randomization.
• \. 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.
• \. 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).
• \. 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.
• \. Blood or blood component transfusion within 10 days prior to signing the Informed Consent Form and/or at Screening.
• \. 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.
• \. 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.
• \. History of systemic anti-angiogenic therapy (e.g., use of anti-angiopoietin, bevacizumab, aflibercept, ranibizumab, pegaptanib, cetuximab, panitumumab, etc.).
• \. Systemic use of glucocorticosteroids within 180 days prior to randomization (more than 10 mg of prednisone equivalent received daily).
• \. Pregnancy or breast-feeding.
• Ophthalmic criteria:
• Study eye:
• \. Causes of MNV other than nAMD (e.g., ocular histoplasmosis, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia, post-traumatic MNV, etc.).

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (14)

Cheboksary branch of S. Fyodorov Eye Microsurgery Federal State Institution

Cheboksary, Cheboksary, 428028, Russia

NOT YET RECRUITING

Medical organization "Optic-Center" Ltd

Chelyabinsk, Chelyabinsk Oblast, 454007, Russia

NOT YET RECRUITING

Sverdlovsk Regional Clinical Hospital No.1

Yekaterinburg, Ekaterinburg, 620109, Russia

NOT YET RECRUITING

Ivanovo regional clinical hospital

Ivanovo, Ivanovo Oblast, 153040, Russia

RECRUITING

Federal State Budgetary Institution "Helmholtz National Medical Research Center of Eye Diseases" of the Ministry of Health of the Russian Federation

Moscow, Moscow, 105062, Russia

NOT YET RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine"

Moscow, Moscow, 127006, Russia

NOT YET RECRUITING

S.Fyodorov Eye Microsurgery Federal State Institution

Moscow, Moscow, 127486, Russia

NOT YET RECRUITING

Volga District Medical Center of the Federal Medical and Biological Agency

Nizhny Novgorod, Nizhny Novgorod Oblast, 603001, Russia

RECRUITING

Novosibirsk Regional Clinical Hospital

Novosibirsk, Novosibirsk Oblast, 630087, Russia

NOT YET RECRUITING

V.P. Vykhodtsev Clinical Ophthalmology Hospital

Omsk, Omsk Oblast, 644024, Russia

NOT YET RECRUITING

S.M. Kirov Military Medical Academy

Saint Petersburg, Saint Peterburg, 194044, Russia

NOT YET RECRUITING

X7 Clinical Research Co

Saint Petersburg, Saint Peterburg, 194156, Russia

NOT YET RECRUITING

LLC "Eye Diseases Clinic"

Kazan', Tatarstan Republic, 420066, Russia

NOT YET RECRUITING

LLC Eyes Clinic-Opticstyle

Vladimir, Vladimirskaya Oblast’, 600017, Russia

NOT YET RECRUITING

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Oksana Markova, MD

CONTACT

+7 9854418959; oamarkova@generium.ru

Anton Seleznev, MD

CONTACT

+7 (495) 988-47-94; ai.seleznev@generium.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 28, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

RU (14)