nAMDPhase 3NCT07844148
A Study to Compare GNR-139 and Eylea® in Patients With nAMD
A Phase 3 study testing aflibercept and Eylea in people with nAMD, run by AO GENERIUM at 14 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- nAMD
- What is being tested?
- aflibercept and Eylea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 14 sitesRussia
- Study dates
- 22 Jul 2026to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
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- 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 the investigator, will either require surgical intervention during the study to prevent or treat potential vision loss resulting from such disease, or will affect the interpretation of study results.
- 27. Use of prohibited medications and/or treatment methods: 27.1. Prior treatment of the study eye with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or laser retinal treatment (e.g., panretinal laser photocoagulation, macular laser photocoagulation, or focal laser photocoagulation).
- 27.2. History of vitrectomy, macular surgery, or any other surgical intervention in the structures of the study eye secondary to AMD.
- 27.3. History of corneal transplantation. 27.4. Prior vitreoretinal surgery and/or scleral buckling. 27.5. Any other intraocular surgical intervention (including cataract surgery) in the structures of the study eye within 90 days prior to signing the Informed Consent Form.
- 27.6. Any prior anti-angiogenic therapy (e.g., anti-angiopoietin, bevacizumab, aflibercept, ranibizumab, pegaptanib, etc.) or treatment of AMD with any investigational medicinal product.
- 27.7. YAG capsulotomy in the study eye within 30 days prior to signing the Informed Consent Form.
- 27.8. Intraocular or periocular administration of glucocorticosteroids within 120 days prior to randomization, or any treatment using an intraocular implant, gene therapy, or cell therapy at any time.
- 27.9. Use of topical (eye drops) glucocorticosteroids for ≥ 30 consecutive days or for ≥ 60 non-consecutive days within 90 days prior to signing the Informed Consent Form.
- 27.10. Use of medicinal products with established toxicity to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, and ethambutol, within 60 days prior to signing the Informed Consent Form.
- 27.11. History of ocriplasmin use.
- Fellow eye:
- 28. Any ocular disease, including AMD, that, in the opinion of the investigator, may require anti-angiogenic therapy within 8 weeks after randomization (aflibercept IVIs will be permitted after Week 8 procedures have been performed).
- 29. Use of prohibited medications and/or treatment methods: 29.1. Any prior anti-angiogenic therapy (e.g., anti-angiopoietin, bevacizumab, aflibercept, ranibizumab, pegaptanib, etc.) or treatment of AMD with any investigational medicinal product within 180 days or 5 t1/2 (whichever is longer) prior to signing the informed consent form.
- 29.2. Any treatment using an intraocular implant, gene therapy, or cell therapy at any time.
- 29.3. Use of medicinal products with established toxicity to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, and ethambutol, within 60 days prior to signing the informed consent form.
- Both eyes:
- 30. History and/or presence at screening of clinical manifestations of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy), DME, or any other retinal vascular disease (RVO, etc.).
- 31. Active neovascularization of the iris, vitreous hemorrhage, or tractional retinal detachment.
- 32. History of idiopathic or autoimmune uveitis. 33. Active or suspected periocular, extraocular, or intraocular infection, including infectious blepharitis, keratitis, scleritis, or conjunctivitis, within 14 days prior to signing the informed consent form and/or at screening.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Russia14 sites, 14 recruiting
- Not yet recruiting
Cheboksary branch of S. Fyodorov Eye Microsurgery Federal State Institution
Cheboksary, Cheboksary, 428028
Anna Voskresenskaya, Ph.D
- Not yet recruiting
Medical organization "Optic-Center" Ltd
Chelyabinsk, Chelyabinsk Oblast, 454007
Elena Tur, Ph.D
- Recruiting
Ivanovo regional clinical hospital
Ivanovo, Ivanovo Oblast, 153040
Aleksey Seleznev, Ph.D
- Not yet recruiting
LLC "Eye Diseases Clinic"
Kazan', Tatarstan Republic, 420066
Elmira Abdulaeva, Ph.D
- Not yet 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
Natalia Neroeva, M.D.
- Not yet recruiting
Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine"
Moscow, Moscow, 127006
Natalia Gavrilova, M.D.
- Not yet recruiting
S.Fyodorov Eye Microsurgery Federal State Institution
Moscow, Moscow, 127486
Marina Sarkisova, M.D.
- Recruiting
Volga District Medical Center of the Federal Medical and Biological Agency
Nizhny Novgorod, Nizhny Novgorod Oblast, 603001
Sergey Svetozarskiy, Ph.D
- Not yet recruiting
Novosibirsk Regional Clinical Hospital
Novosibirsk, Novosibirsk Oblast, 630087
Anzhella Fursova, M.D.
- Not yet recruiting
V.P. Vykhodtsev Clinical Ophthalmology Hospital
Omsk, Omsk Oblast, 644024
Oleg Lebedev, M.D.
- Not yet recruiting
S.M. Kirov Military Medical Academy
Saint Petersburg, Saint Peterburg, 194044
Aleksey Kulikov
- Not yet recruiting
X7 Clinical Research Co
Saint Petersburg, Saint Peterburg, 194156
Paul Nechiporenko, M.D.
- Not yet recruiting
LLC Eyes Clinic-Opticstyle
Vladimir, Vladimirskaya Oblast’, 600017
Alexander Kuskov, M.D.
- Not yet recruiting
Sverdlovsk Regional Clinical Hospital No.1
Yekaterinburg, Ekaterinburg, 620109
Irina Ionkina, M.D.
About this study
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GNR-139 in Comparison With Eylea® (114.3 mg/mL) in Patients With nAMD
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).
Read more
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
- Being tested
- aflibercept, Eylea
- Keywords
- Neovascular Age-Related Macular Degeneration, nAMD, GNR-139, Biosimilar, High-Dose Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptBiological
GNR-139 is being developed as a biosimilar to the reference medicinal product Eylea®
EyleaBiological
Eylea® (INN: aflibercept), 114.3 mg/mL, solution for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Group I (GNR-139): 120 patients | Experimental | GNR-139 is being developed as a biosimilar to the reference medicinal product Eylea® Receives: Biological: aflibercept |
| Group II (Eylea®): 60 patients | Active comparator | Not described Receives: Biological: Eylea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a reduction in RPE detachment (both serous and fibrovascular) based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Measured: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a gain of ≥ 5, 10, or 15 letters in BCVA on the ETDRS chart at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Measured: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a loss of ≥ 5, 10, or 15 letters in BCVA on the ETDRS chart at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Measured: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Number of IVIs received during the study period
Measured: From enrollment to the end of week 56
Proportion of patients who required interval shortening between IVIs during the study
Measured: Baseline - Week 56
Proportion of patients for whom interval extension was possible during the study
Measured: Baseline - Week 56
Proportion of patients who did not require interval adjustment during the study
Measured: Baseline - Week 56
Change from baseline** in MNV area based on FFA data at Week 12, Week 24, and Week 56
** baseline value is defined as the value of the endpoint at Screening
Measured: Baseline - Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start22 Jul 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for nAMDStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844148
- Sponsor's protocol ID
- GNR139-AMD03
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GNR-139 in Comparison With Eylea® (114.3 mg/mL) in Patients With nAMD
- ClinicalTrials.gov ID
- NCT07844148
- Acronym / sponsor ID
- GNR139-AMD03
- Conditions
- nAMD
- Keywords
- Neovascular Age-Related Macular Degeneration, nAMD, GNR-139, Biosimilar, High-Dose Aflibercept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Sep 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (GNR-139): 120 patients | Experimental | Biological: afliberceptGNR-139 is being developed as a biosimilar to the reference medicinal product Eylea® |
| Group II (Eylea®): 60 patients | Active comparator | Biological: Eylea |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (41 listed)
- 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).
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 |
|---|---|---|
| afliberceptGNR-139 is being developed as a biosimilar to the reference medicinal product Eylea® | Biological | Group I (GNR-139): 120 patients |
| EyleaEylea® (INN: aflibercept), 114.3 mg/mL, solution for intravitreal injection | Biological | Group II (Eylea®): 60 patients |
Primary outcome
Change from baseline in BCVA, assessed by the number of letters read correctly on the ETDRS chart, at Week 8.
Time frame: Week 8
This endpoint will be used to evaluate the therapeutic equivalence of GNR-139 and Eylea® in terms of functional ophthalmic outcome
13 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a reduction in RPE detachment (both serous and fibrovascular) based on OCT data at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Time frame: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a gain of ≥ 5, 10, or 15 letters in BCVA on the ETDRS chart at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Time frame: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Proportion of patients with a loss of ≥ 5, 10, or 15 letters in BCVA on the ETDRS chart at Weeks 4, 8, 12, 16, 20, 24, 40, and 56 compared to baseline
Time frame: Weeks 4, 8, 12, 16, 20, 24, 40, and 56
Number of IVIs received during the study period
Time frame: From enrollment to the end of week 56
Proportion of patients who required interval shortening between IVIs during the study
Time frame: Baseline - Week 56
Proportion of patients for whom interval extension was possible during the study
Time frame: Baseline - Week 56
Proportion of patients who did not require interval adjustment during the study
Time frame: Baseline - Week 56
Change from baseline** in MNV area based on FFA data at Week 12, Week 24, and Week 56
Time frame: Baseline - Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
14 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 aflibercept and Eylea in people with nAMD, run by AO GENERIUM at 14 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 8 inclusion and 41 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oksana Markova, MD (+7 9854418959, oamarkova@generium.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BCVA, assessed by the number of letters read correctly on the ETDRS chart, at Week 8. (time frame: Week 8). 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 30 Sep 2026.