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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04200248•Ribomic USA Inc

View on ClinicalTrials.gov

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

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (8)

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Retinal Consultants Medical Group

Sacramento, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Advanced Research, LLC

Coral Springs, Florida, United States

Georgia Retina, P.C.

Marietta, Georgia, United States

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, United States

Valley Retina Institute, PA

McAllen, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Key Dates

Start Date

December 2, 2019

Primary Completion Date

November 19, 2021

Completion Date

December 22, 2021

Last Updated

June 8, 2023

Enrollment

ACTUAL participants

Conditions

Exudative Age-related Macular Degeneration

Interventions

RBM-007 Injectable Solution

DRUG

Aflibercept

DRUG

Sham

DRUG

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

NCT05703867

View study

COMPLETEDPHASE2

LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

NCT02355028

Exudative Age-Related Macular Degeneration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD

ESBA1008 Microvolume Study

LUCAS (Lucentis Compared to Avastin Study)

Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration