Skip to main content
OpenTrials
Completed

NCT Number: NCT04200248

A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exudative Age-Related Macular Degeneration Edema Fibrosis Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

Loading trial locations.

About this study

RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity

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.
  • Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures.
  • Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography.
  • Presence of macular edema or subretinal fluid.
  • Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
  • Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
  • Visual acuity of 24 letters (20/320) or better in the fellow eye.
  • Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography

Exclusion criteria

  • Ocular:
  • Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
  • Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
  • Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
  • Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
  • Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
  • Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye.
  • Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study
  • History of vitrectomy in the study eye.
  • Need for ocular surgery in the study eye during the course of the study.
  • YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
  • Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.

Treatment and study plan

RBM-007 Injectable Solution

Drug

RBM-007 Injectable Solution

aflibercept

Drug

EYLEA® (aflibercept) Injection, for Intravitreal Use

sham

Drug

Sham intravitreal injection

Primary outcomes

  1. Visual Acuity - Continuous

    Time frame: Week 16

    Mean change in Best Corrected Visual Acuity from Baseline to Week 16

Secondary outcomes

  1. Visual Acuity - Categorical

    Time frame: Week 16

    Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16

  2. Macular Thickness Change

    Time frame: Week 16

    Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16

  3. Macular Volume Change

    Time frame: Week 16

    Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16

  4. Fibrosis Change

    Time frame: Week 16

    Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16

  5. Safety - Ocular

    Time frame: Week 20

    Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities

Sponsors and collaborators

Lead sponsor

Ribomic USA Inc

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of RBM-007 Monotherapy and RBM-007 in Combination With Eylea® Compared to Eylea® Monotherapy

Acronym: TOFU

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2019
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.