A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

Study Overview
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Brief Summary
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This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

Detailed Description
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RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity

Official Title
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A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of RBM-007 Monotherapy and RBM-007 in Combination With Eylea® Compared to Eylea® Monotherapy

Conditions
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Exudative Age-related Macular Degeneration

Intervention / Treatment
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* Drug: RBM-007 Injectable Solution
* Drug: Aflibercept
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed written informed consent. Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures. Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography. Presence of macular edema or subretinal fluid. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye. Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye. Visual acuity of 24 letters (20/320) or better in the fellow eye. Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography Exclusion Criteria: Ocular: Use of any of the following treatments or anticipated use of any of the following treatments to the study eye: Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1). Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study. Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study. Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study. Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye. Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study History of vitrectomy in the study eye. Need for ocular surgery in the study eye during the course of the study. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye. Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham + RBM-007<br>Sham + RBM-007 intravitreal injection | Drug: RBM-007 Injectable Solution<br>* RBM-007 Injectable Solution<br>Drug: Sham<br>* Sham intravitreal injection<br>|
| Experimental: RBM-007 + Aflibercept<br>RBM-007 + Aflibercept intravitreal injection | Drug: RBM-007 Injectable Solution<br>* RBM-007 Injectable Solution<br>Drug: Aflibercept<br>* EYLEA® (aflibercept) Injection, for Intravitreal Use<br>|
| Active Comparator: Sham + Aflibercept<br>Sham + Aflibercept intravitreal injection | Drug: Aflibercept<br>* EYLEA® (aflibercept) Injection, for Intravitreal Use<br>Drug: Sham<br>* Sham 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 to Week 16 | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Categorical | Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16 | Week 16 | 
| Macular Thickness Change | Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16 | Week 16 | 
| Macular Volume Change | Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16 | Week 16 | 
| Fibrosis Change | Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16 | Week 16 | 
| Safety - Ocular | Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities | Week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrosis, Edema, Neovascularization