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

NCT06470373 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PD-CP-Y1
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Outcome Measures

Primary Outcomes (1)

• Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment

  The change from baseline (Day 1) to 8 weeks after the IP treatment

Secondary Outcomes (1)

• Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 4, 8, 12, 16, 20, and 24 weeks after the IP treatment

  The change from baseline (Day 1) to 4, 8, 12, 16, 20, and 24 weeks after the IP treatment

Study Arms (2)

RBS-001 treatment group

ACTIVE COMPARATOR

All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score

Drug: RBS-001 Solution for intravitreal injection

Eylea® treatment group

ACTIVE COMPARATOR

All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score

Drug: Eylea® Solution for intravitreal injection

Interventions

RBS-001 Solution for intravitreal injection DRUG

Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye

RBS-001 treatment group

Eylea® Solution for intravitreal injection DRUG

Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye

Eylea® treatment group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rophibio, Inc.: lead

Study Sites (7)

Associated Retina Consultants - Phoenix

Phoenix, Arizona, 85021, United States

Location

Associated Retina Consultants - Gilbert

Phoenix, Arizona, 85297, United States

Location

Retina Partners of Northwest Arkansas, PLLC

Springdale, Arkansas, 72764, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Matthew Gaver, BS

CONTACT

240-454-6833; matthewg@amarexcro.com

Study Design

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

Model Details: This is a multinational, multi-center, randomized, double-masked, parallel, phase 3 clinical study.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (7)