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Phase 2 N=22 Treatment

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

Exudative Age-related Macular Degeneration

Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Jun 2023
Primary outcome: Primary: Visual Acuity - Continuous — -5.5 Letter seen on eye chart

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
RBM-007 (Drug)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
Ribomic USA Inc
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity - Continuous
-5.5
SECONDARY
Visual Acuity - Categorical
SECONDARY
Change From Baseline in Central Macular Subfield Thickness
55.9

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.

Eligibility Criteria

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

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04640272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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