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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 : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ribomic USA Inc

Study Description
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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).

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: RBM-007 Injectable Solution Drug: Aflibercept Drug: Sham Phase 2

Detailed Description:
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sham + RBM-007
Sham + RBM-007 intravitreal injection
 Drug: RBM-007 Injectable Solution
RBM-007 Injectable Solution

Drug: Sham
Sham intravitreal injection
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: Aflibercept
EYLEA® (aflibercept) Injection, for Intravitreal Use

Drug: Sham
Sham intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity - continuous [ Time Frame: Week 16 ]
    Mean change in Best Corrected Visual Acuity from Baseline


Secondary Outcome Measures :
  1. Visual acuity - categorical [ Time Frame: Week 16 ]
    Proportion of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline

  2. Macular thickness change [ Time Frame: Week 16 ]
    Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography

  3. Macular volume change [ Time Frame: Week 16 ]
    Change from Baseline in macular volume by spectral domain optical coherence tomography

  4. Fibrosis change [ Time Frame: Week 16 ]
    Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography

  5. Safety - Ocular [ Time Frame: Week 20 ]
    Ocular examination (biomicroscopy and ophthalmoscopy)

  6. Safety - Systemic - Heart rate [ Time Frame: Week 20 ]
    Change in heart rate (beats per minute)

  7. Safety - Systemic - Blood pressure [ Time Frame: Week 20 ]
    Change in systolic and diastolic blood pressure (millimeters of mercury)


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200248


Contacts
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Contact: Yusuf Ali, Ph.D. (707) 287-4313 yusuf.ali@ribomic.com
Contact: Daniel Pereira, M.D. (415) 341-4996 daniel.pereira@ribomic.com

Locations
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United States, California
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94704
Contact: Sarah Manz    925-943-6800    smanz@bayarearetina.com   
Principal Investigator: Subhransu Ray, MD         
Sponsors and Collaborators
Ribomic USA Inc
Investigators
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Study Director: Yusuf Ali, Ph.D. Ribomic USA
More Information
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Responsible Party: Ribomic USA Inc
ClinicalTrials.gov Identifier: NCT04200248    
Other Study ID Numbers: RBM 007-002
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ribomic USA Inc:
Fibrosis
Edema
Neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions