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

Exudative Age-related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200248
• Other study ID #: RBM 007-002
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2019
• Est. completion date: December 22, 2021

Study information

• Verified date: April 2023
• Source: Ribomic USA Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 22, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• RBM-007 Injectable Solution
RBM-007 Injectable Solution
• Aflibercept
EYLEA® (aflibercept) Injection, for Intravitreal Use
• Sham
Sham intravitreal injection

Locations

Country	Name	City	State
United States	Advanced Research, LLC	Coral Springs	Florida
United States	Raj K. Maturi, M.D., P.C.	Indianapolis	Indiana
United States	Georgia Retina, P.C.	Marietta	Georgia
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Ribomic USA Inc

Country where clinical trial is conducted

United States, 

Outcome

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