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

NCT04200248 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RBM 007-002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 8

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).

Conditions

Exudative Age-related Macular Degeneration

Keywords

Fibrosis; Edema; Neovascularization

Outcome Measures

Primary Outcomes (1)

• Visual Acuity - Continuous

  Mean change in Best Corrected Visual Acuity from Baseline to Week 16

  Week 16

Secondary Outcomes (5)

• Visual Acuity - Categorical

  Week 16

• Macular Thickness Change

  Week 16

• Macular Volume Change

  Week 16

• Fibrosis Change

  Week 16

• Safety - Ocular

  Week 20

Study Arms (3)

Sham + RBM-007

EXPERIMENTAL

Sham + RBM-007 intravitreal injection

Drug: RBM-007 Injectable Solution; Drug: Sham

RBM-007 + Aflibercept

EXPERIMENTAL

RBM-007 + Aflibercept intravitreal injection

Drug: RBM-007 Injectable Solution; Drug: Aflibercept

Sham + Aflibercept

ACTIVE COMPARATOR

Sham + Aflibercept intravitreal injection

Drug: Aflibercept; Drug: Sham

Interventions

RBM-007 Injectable Solution DRUG

RBM-007 Injectable Solution

RBM-007 + Aflibercept; Sham + RBM-007

Aflibercept DRUG

EYLEA® (aflibercept) Injection, for Intravitreal Use

RBM-007 + Aflibercept; Sham + Aflibercept

Sham DRUG

Sham intravitreal injection

Sham + Aflibercept; Sham + RBM-007

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ribomic USA Inc: lead

Study Sites (8)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94704, United States

Location

Advanced Research, LLC

Coral Springs, Florida, 33067, United States

Location

Georgia Retina, P.C.

Marietta, Georgia, 30060, United States

Location

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

Indianapolis, Indiana, 46290, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Fibrosis; Edema; Neovascularization, Pathologic

Interventions

aflibercept; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Metaplasia

Results Point of Contact

• Title: Dr. Yoshikazu Nakamura
• Organization: Ribomic, Inc.

yoshi@ribomic.com

81-3-3440-3303

Study Officials

• Padma Bezwada, Ph.D.

  RIBOMIC USA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 16, 2019
• Study Start: December 2, 2019
• Primary Completion: November 19, 2021
• Study Completion: December 22, 2021
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)