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

ConditionNeovascular Age-related Macular Degeneration (nAMD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorRophibio, Inc.

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

434 Participants
are divided into 2 treatment groups
Group A: RBS-001 treatment groupActive comparator 1 intervention
Group B: Eylea® treatment groupActive comparator 1 intervention

Trial outcomes

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

Time frame
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

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

Other outcomes

Sponsors and contacts

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

Rophibio, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: