A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration

Study Overview
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Brief Summary
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This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.

Official Title
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A Multi-Center, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration

Conditions
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Exudative Age-related Macular Degeneration

Intervention / Treatment
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* Drug: RBM-007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations. Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures. Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT). Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye. Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography. Exclusion Criteria: 1. Subjects whose vision have improved >15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, non-comparative
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBM-007 injectable solution<br>intravitreal injection | Drug: RBM-007<br>* Intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Continuous | Mean change in Best Corrected Visual Acuity from Baseline | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Categorical | Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline | Month 4 | 
| Change From Baseline in Central Macular Subfield Thickness |  | Month 4 |