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

Completed · Phase 2 · Has a placebo group

Conditions studied: Exudative Age-related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT04200248

Run by

Ribomic USA Inc

People needed

94

Starts

2019-12-02

Expected to finish

2021-12-22

Last updated by the study team

2023-06-08

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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