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

ConditionnAMD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorAO GENERIUM

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Men and women aged ≥ 50 years at the time of signing the Informed Consent Form.

Disqualifiers

1. Known hypersensitivity to aflibercept or to any of the excipients contained in GNR-139 or Eylea®.

Trial design

Design model

Parallel

Treatments tested in this trial

  • aflibercept

    Biological/Vaccine

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

  • Eylea

    Biological/Vaccine

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Group I (GNR-139): 120 patientsExperimental treatment 1 intervention
Group B: Group II (Eylea®): 60 patientsActive comparator 1 intervention

Trial outcomes

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

Time frame
Week 8

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AO GENERIUM

Lead sponsor

Source ClinicalTrials.gov
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