A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration

NCT04640272 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RBM 007-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multi-center, open label, extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 in subjects with wet age-related macular degeneration.

Conditions

Exudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Visual Acuity - Continuous

  Mean change in Best Corrected Visual Acuity from Baseline

  Month 4

Secondary Outcomes (2)

• Visual Acuity - Categorical

  Month 4

• Change From Baseline in Central Macular Subfield Thickness

  Month 4

Study Arms (1)

RBM-007 injectable solution

EXPERIMENTAL

intravitreal injection

Drug: RBM-007

Interventions

RBM-007 DRUG

Intravitreal injection

RBM-007 injectable solution

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 on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
• Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and study procedures.
• Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study
• Subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents Eylea® and/or RBM-007 has not demonstrated improvement in vision; subjects with less than 15 letter Best Corrected Visual Acuity (BCVA) improvement in TOFU study at exit visit over its baseline.
• Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).
• Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.
• BCVA of 24 ETDRS letters (20/320) or better in the fellow eye.
• Reasonably clear media and some fixation in the study eye to allow for good quality SD-OCT and fundus photography.

You may not qualify if:

• \. Subjects whose vision have improved \>15 BCVA letters at exit visit of previous study over its baseline 2. Subjects who experienced any drug related serious adverse event during previous study

Sponsors & Collaborators

• Ribomic USA Inc: lead

Study Sites (6)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Retinal Medical Consultants Group

Sacramento, California, 95841, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94704, United States

Location

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

Indianapolis, Indiana, 46290, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Results Point of Contact

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

yoshi@ribomic.com

81-3-3440-3303

Study Officials

• Padma Bezwada, PhD

  Ribomic USA Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, non-comparative

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 3, 2020
• Primary Completion: November 19, 2021
• Study Completion: December 22, 2021
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)