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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200248
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ribomic USA Inc

Tracking Information
First Submitted Date  ICMJE December 8, 2019
First Posted Date  ICMJE December 16, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE December 2, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
Visual acuity - continuous [ Time Frame: Week 16 ]
Mean change in Best Corrected Visual Acuity from Baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • Visual acuity - categorical [ Time Frame: Week 16 ]
    Proportion of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline
  • Macular thickness change [ Time Frame: Week 16 ]
    Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography
  • Macular volume change [ Time Frame: Week 16 ]
    Change from Baseline in macular volume by spectral domain optical coherence tomography
  • Fibrosis change [ Time Frame: Week 16 ]
    Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography
  • Safety - Ocular [ Time Frame: Week 20 ]
    Ocular examination (biomicroscopy and ophthalmoscopy)
  • Safety - Systemic - Heart rate [ Time Frame: Week 20 ]
    Change in heart rate (beats per minute)
  • Safety - Systemic - Blood pressure [ Time Frame: Week 20 ]
    Change in systolic and diastolic blood pressure (millimeters of mercury)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Exudative Age-related Macular Degeneration
Intervention  ICMJE
  • Drug: RBM-007 Injectable Solution
    RBM-007 Injectable Solution
  • Drug: Aflibercept
    EYLEA® (aflibercept) Injection, for Intravitreal Use
  • Drug: Sham
    Sham intravitreal injection
Study Arms  ICMJE
  • Experimental: Sham + RBM-007
    Sham + RBM-007 intravitreal injection
    Interventions:
    • Drug: RBM-007 Injectable Solution
    • Drug: Sham
  • Experimental: RBM-007 + Aflibercept
    RBM-007 + Aflibercept intravitreal injection
    Interventions:
    • Drug: RBM-007 Injectable Solution
    • Drug: Aflibercept
  • Active Comparator: Sham + Aflibercept
    Sham + Aflibercept intravitreal injection
    Interventions:
    • Drug: Aflibercept
    • Drug: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yusuf Ali, Ph.D. (707) 287-4313 yusuf.ali@ribomic.com
Contact: Daniel Pereira, M.D. (415) 341-4996 daniel.pereira@ribomic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04200248
Other Study ID Numbers  ICMJE RBM 007-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ribomic USA Inc
Study Sponsor  ICMJE Ribomic USA Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yusuf Ali, Ph.D. Ribomic USA
PRS Account Ribomic USA Inc
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP