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

Phase 2

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: Aflibercept; Drug: RBM-007 Injectable Solution; Drug: Sham

• Registration Number: NCT04200248
• Lead Sponsor: Ribomic USA Inc

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 Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Primary Completion: 2021-11-19
• Study Completion: 2021-12-22
• Results First Submitted: 2023-03-27
• Status Verified: 2023-04
• Results First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Results First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham + Aflibercept	Aflibercept	Sham + Aflibercept intravitreal injection
Sham + Aflibercept	Sham	Sham + Aflibercept intravitreal injection
Sham + RBM-007	RBM-007 Injectable Solution	Sham + RBM-007 intravitreal injection
Sham + RBM-007	Sham	Sham + RBM-007 intravitreal injection
RBM-007 + Aflibercept	RBM-007 Injectable Solution	RBM-007 + Aflibercept intravitreal injection
RBM-007 + Aflibercept	Aflibercept	RBM-007 + Aflibercept intravitreal injection

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Valley Retina Institute, PA; 🇺🇸 McAllen, Texas, United States

Advanced Research, LLC; 🇺🇸 Coral Springs, Florida, United States

Retinal Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Georgia Retina, P.C.; 🇺🇸 Marietta, Georgia, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States

Raj K. Maturi, M.D., P.C.; 🇺🇸 Indianapolis, Indiana, United States