NCT04200248

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Ribomic USA Inc · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Exudative Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	RBM-007 Injectable Solution	RBM-007 Injectable Solution
DRUG	Aflibercept	EYLEA® (aflibercept) Injection, for Intravitreal Use
DRUG	Sham	Sham intravitreal injection

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-11-19
• Completion: 2021-12-22
• First posted: 2019-12-16
• Last updated: 2023-06-08
• Results posted: 2023-06-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study