RBS-001 vs Eylea for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rophibio, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Neovascular Age-Related Macular Degeneration. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have the condition being studied.

Inclusion Criteria

I am 50 years old or older.

Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye

My eye condition involves fluid buildup confirmed by an OCT scan.

+3 more

Exclusion Criteria

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

+6 more

Participant Groups

The study tests RBS-001 against Eylea®, both treatments for macular degeneration. It aims to compare their effectiveness, safety, tolerability, and potential to cause immune reactions in patients.

2Treatment groups

Active Control

Group I: RBS-001 treatment groupActive Control1 Intervention

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

Group II: Eylea® treatment groupActive Control1 Intervention

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