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

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RBM-007 Injectable Solution
Aflibercept
Sham
Sponsored by
Ribomic USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring Fibrosis, Edema, Neovascularization

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retinal Research Institute, LLC
  • Retinal Consultants Medical Group
  • Bay Area Retina Associates
  • Advanced Research, LLC
  • Georgia Retina, P.C.
  • Raj K. Maturi, M.D., P.C.
  • Valley Retina Institute, PA
  • Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Sham + RBM-007

RBM-007 + Aflibercept

Sham + Aflibercept

Arm Description

Sham + RBM-007 intravitreal injection

RBM-007 + Aflibercept intravitreal injection

Sham + Aflibercept intravitreal injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2019
Last Updated
May 11, 2023
Sponsor
Ribomic USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04200248
Brief Title
A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Acronym
TOFU
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ribomic USA Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
Fibrosis, Edema, Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham + RBM-007
Arm Type
Experimental
Arm Description
Sham + RBM-007 intravitreal injection
Arm Title
RBM-007 + Aflibercept
Arm Type
Experimental
Arm Description
RBM-007 + Aflibercept intravitreal injection
Arm Title
Sham + Aflibercept
Arm Type
Active Comparator
Arm Description
Sham + Aflibercept intravitreal injection
Intervention Type
Drug
Intervention Name(s)
RBM-007 Injectable Solution
Intervention Description
RBM-007 Injectable Solution
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
EYLEA® (aflibercept) Injection, for Intravitreal Use
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
Sham intravitreal injection
Primary Outcome Measure Information:
Title
Visual Acuity - Continuous
Description
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Visual Acuity - Categorical
Description
Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16
Time Frame
Week 16
Title
Macular Thickness Change
Description
Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16
Time Frame
Week 16
Title
Macular Volume Change
Description
Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16
Time Frame
Week 16
Title
Fibrosis Change
Description
Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16
Time Frame
Week 16
Title
Safety - Ocular
Description
Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities
Time Frame
Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Padma Bezwada, Ph.D.
Organizational Affiliation
RIBOMIC USA
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Advanced Research, LLC
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Georgia Retina, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Raj K. Maturi, M.D., P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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