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OpenTrials
Completed

NCT Number: NCT04640272

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Research Institute, LLC, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBM-007

Drug

Intravitreal injection

Primary outcomes

  1. Visual Acuity - Continuous

    Time frame: Month 4

    Mean change in Best Corrected Visual Acuity from Baseline

Secondary outcomes

  1. Visual Acuity - Categorical

    Time frame: Month 4

    Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline

  2. Change From Baseline in Central Macular Subfield Thickness

    Time frame: Month 4

Sponsors and collaborators

Lead sponsor

Ribomic USA Inc

Industry

Registry information

Official study title

A Multi-Center, Open Label, TOFU Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration

Acronym: RAMEN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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