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

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

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).

Study Overview

• Status: Completed
• Conditions: Exudative Age-related Macular Degeneration
• Intervention / Treatment: Drug: Sham; Drug: RBM-007 Injectable Solution; Drug: Aflibercept

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retinal Research Institute, LLC
  • California
    • Sacramento, California, United States, 95841
      • Retinal Consultants Medical Group
    • Walnut Creek, California, United States, 94704
      • Bay Area Retina Associates
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Advanced Research, LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Retina, P.C.
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, M.D., P.C.
  • Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute, PA
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide signed written informed consent.
2. 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.
3. 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.
4. Presence of macular edema or subretinal fluid.
5. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
6. Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
7. Visual acuity of 24 letters (20/320) or better in the fellow eye.
8. Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography

Exclusion Criteria:

• Ocular:

  1. Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:

     1. Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
     2. Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
     3. Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
     4. Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
  2. 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.
  3. 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
  4. History of vitrectomy in the study eye.
  5. Need for ocular surgery in the study eye during the course of the study.
  6. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
  7. Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham + RBM-007; Sham + RBM-007 intravitreal injection	Drug: Sham; Sham intravitreal injection; Drug: RBM-007 Injectable Solution; RBM-007 Injectable Solution
Experimental: RBM-007 + Aflibercept; RBM-007 + Aflibercept intravitreal injection	Drug: RBM-007 Injectable Solution; RBM-007 Injectable Solution; Drug: Aflibercept; EYLEA® (aflibercept) Injection, for Intravitreal Use
Active Comparator: Sham + Aflibercept; Sham + Aflibercept intravitreal injection	Drug: Sham; Sham intravitreal injection; Drug: Aflibercept; EYLEA® (aflibercept) Injection, for Intravitreal Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity - Continuous	Mean change in Best Corrected Visual Acuity from Baseline to Week 16	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity - Categorical	Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16	Week 16
Macular Thickness Change	Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16	Week 16
Macular Volume Change	Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16	Week 16
Fibrosis Change	Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16	Week 16
Safety - Ocular	Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities	Week 20

Collaborators and Investigators

• Sponsor: Ribomic USA Inc
• Investigators: Study Director: Padma Bezwada, Ph.D., RIBOMIC USA

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fibrosis; Edema; Neovascularization
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: RBM 007-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No