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

Completed · Phase 2

Conditions studied: Exudative Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04640272

Run by

Ribomic USA Inc

People needed

40

Starts

2020-11-03

Expected to finish

2021-12-22

Last updated by the study team

2023-06-08

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Retinal Medical Consultants Group — Sacramento, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• Valley Retina Institute — McAllen, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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