A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration

Starting soon · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration (nAMD)

In brief

This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration.

Key facts

Study ID: NCT06470373
Run by: Rophibio, Inc.
People needed: 434
Starts: 2025-07-01
Expected to finish: 2026-09-01
Last updated by the study team: 2025-04-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 50 years at screening
Individuals with active CNV lesion secondary to AMD in the study eye, proven by fluorescein angiography (FA) and confirmed by the central reading center during the screening period
Individuals with CNV area in the study eye accounting for ≥ 50% of the total lesion, including macular hemorrhage, scar, atrophy, fibrosis and neovascularization, proven by FA and confirmed by the central reading center during the screening period
Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical coherence tomography (OCT) and confirmed by the central reading center during the screening period
Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye
Individuals who voluntarily decide to participate in the clinical study after being fully informed of the details of the clinical study and who provide written consent to comply with the study instructions during the clinical study

You may not qualify if…

Individuals whose study eye lesion meets any of the following criteria
Total lesion* size - > 23 mm2 [9 disc areas (DAs)] (Must be proven by FA)
Subretinal hemorrhage (or subfoveal hemorrhage) - ≥ 50% of the total lesion* [≥ 1 DA (In the case of subfoveal hemorrhage, fovea must be surrounded 270 degrees by visible CNV.)]
Scar or fibrosis - ≥ 50% of the total lesion* or Scar, fibrosis, or atrophy involving the center of the fovea
Retinal pigment epithelial tears or rips - Macular involvement
Macular hole - At any stage, if present in the study eye
Other causes of CNV - Ocular histoplasmosis syndrome, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia (spherical equivalent of negative 8 diopters or more or axial length of 25 mm or more), etc.
Individuals with any of the following concurrent diseases at screening or for a specified period of time
i. Concurrent ocular disease ii. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (despite adequate treatment) iii. Uncontrolled diabetes mellitus, at the investigator's discretion iv. Congestive heart failure with New York Heart Association (NYHA) functional classification 3 or 4 or any clinically significant heart disease including ventricular arrhythmia and atrial fibrillation, at the investigator's discretion v. Active systemic infection undergoing treatment or recurrent clinically significant infections within 4 weeks prior to the first dose of the IP
Individuals with any medical history of the following at screening:
i. Other ophthalmic disease in the study eye that may affect safety/efficacy assessments in the subject or may require medical/surgical interventions during the clinical study at the investigator's discretion (e.g., vitreomacular traction, glaucoma undergoing treatment, retinal detachment, corneal dystrophy, etc.) ii. Diabetic retinopathy (DR)*, diabetic macular edema (DME), retinal vein occlusion (RVO), uveitis, or other vascular disease affecting the retina (other than nAMD) in either eye *Mild non-proliferative DR will be permitted.
iii. Stroke, transient ischemic attack, pulmonary embolism, deep venous thrombosis or myocardial infarction within the past 24 weeks iv. Hypersensitivity reactions to aflibercept or other drugs to be used in the clinical study (fluorescein, mydriatic drops, etc.) v. Malignancy within the last 5 years (however, individuals with basal cell, cutaneous squamous cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma who are in stable long-term follow-up without therapeutic medication, procedures, or surgery can participate in this clinical trial) vi. Organ or bone marrow transplantation
Individuals with a history of any of the following medication or non-pharmacological treatment for the study eye i. Glaucoma filtering surgery, vitrectomy or corneal transplantation ii. Simple intraocular or periocular surgery (e.g., cataract surgery, simple neodymium yttrium aluminum garnet (Nd:YAG) laser capsulotomy on a pseudophakic eye due to posterior capsular opacification, etc.) within 12 weeks or eyelid surgery within 4 weeks prior to the screening visit [Laser iridotomy will be permitted.] iii. Macular photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiotherapy or retinal laser treatment (e.g., focal laser photocoagulation, pan-retinal photocoagulation, etc.) iv. Periocular radiotherapy v. Any anti-VEGF treatment for nAMD (including participation in other clinical studies) vi. Treatment for retinal detachment (medication or non-pharmacological treatment) vii. IVT corticosteroid injection, sub-tenon or periocular corticosteroid injection within 24 weeks or IVT corticosteroid implantation within 36 months prior to the screening visit
Individuals with any of the following medication or non-pharmacological treatment history:
i. Systemic anti-VEGF therapy within 12 weeks prior to the first dose of the IP ii. Any anti-VEGF treatment of nAMD in the fellow eye within 8 weeks prior to the first dose of the IP iii. Current use at screening of medications known to be toxic to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol.
iv. Systemic corticosteroids administered within 12 weeks prior to the first dose of the IP (prednisolone ≤ 10 mg/day and equivalent dose administered for 14 days or less or inhaled/intranasal/dermal agents will be permitted.) v. Other IP within 12 weeks or 5 times the half-life (whichever is longer) prior to the first dose of the IP
Individuals with BCVA of fewer than 34 letters measured by ETDRS letter score at the screening and baseline visits in the fellow eye
Individuals who have only one functional eye (monocular vision)
Pregnant [human chorionic gonadotropin (hCG) positive] or breastfeeding women of childbearing potential at the screening and baseline visits
Men or women of childbearing potential who are unwilling to use adequate methods of contraception* from the time of written informed consent to 12 weeks after the last dose of the IP
Adequate methods of contraception: Hormonal contraceptives (oral contraceptive pill, contraceptive patch, etc.), intrauterine device or intrauterine system implantation, sterilization procedure or surgery (vasectomy, bilateral tubal ligation, etc.), complete abstinence
Individuals considered by the investigator to be ineligible for study participation for any reasons other than the inclusion and exclusion criteria

Where it is running

Associated Retina Consultants - Phoenix — Phoenix, Arizona, United States
Associated Retina Consultants - Gilbert — Phoenix, Arizona, United States
Retina Partners of Northwest Arkansas, PLLC — Springdale, Arkansas, United States
Erie Retina Research — Erie, Pennsylvania, United States
Charles Retina Institute — Germantown, Tennessee, United States
Retina Research Institute of Texas — Abilene, Texas, United States
Strategic Clinical Research Group, LLC — Willow Park, Texas, United States

Full record on ClinicalTrials.gov

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