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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    81
  • sponsor
    Ribomic USA Inc
Updated on 6 July 2021
edema
macular edema
atrophy
aflibercept
eylea
optical coherence tomography
spectral domain optical coherence tomography
age-related macular degeneration

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).

Description

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

Details
Condition Exudative Age Related Macular Degeneration
Treatment SHAM, Aflibercept, RBM-007 Injectable Solution
Clinical Study IdentifierNCT04200248
SponsorRibomic USA Inc
Last Modified on6 July 2021

Eligibility

Yes No Not Sure

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
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