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

Phase 2

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: RBM-007

• Registration Number: NCT04640272
• Lead Sponsor: Ribomic USA Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-03
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Primary Completion: 2021-11-19
• Study Completion: 2021-12-22
• Results First Submitted: 2023-03-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Results First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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.
2. 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.
3. Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
4. 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.
5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
7. BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
8. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RBM-007 injectable solution	RBM-007	intravitreal injection

Primary Outcome Measures

Name	Time	Method
Visual Acuity - Continuous	Month 4	Mean change in Best Corrected Visual Acuity from Baseline

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Retinal Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Retinal Medical Consultants Group; 🇺🇸 Sacramento, California, United States

Raj K. Maturi, M.D., P.C.; 🇺🇸 Indianapolis, Indiana, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States