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Monoclonal Antibodies

RBS-001 vs Eylea for Age-Related Macular Degeneration

Phase 3

Waitlist Available

Research Sponsored by Rophibio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 50 years at screening

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to show that two different treatments, RBS-001 and Eylea, are equally effective and safe in treating a specific eye condition called Neovascular age-related macular degeneration

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, intravitreal injections like RBS-001 and Eylea® may cause eye irritation or discomfort, increased intraocular pressure, or rare complications such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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My eye condition involves over 50% CNV area with complications, confirmed by tests.

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

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My eye condition is confirmed by a special test to be due to AMD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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My eye condition meets specific criteria related to size, bleeding, scarring, or other causes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 9Eligibility criteria met