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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    40
  • sponsor
    Ribomic USA Inc
Updated on 9 July 2021

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.

Details
Condition Exudative Age Related Macular Degeneration
Treatment RBM-007
Clinical Study IdentifierNCT04640272
SponsorRibomic USA Inc
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

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

\. 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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