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

Exudative Age-related Macular Degeneration Clinical Trial

— RAMEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640272
• Other study ID #: RBM 007-003
• Status: Completed
• Phase: Phase 2
• Start date: November 3, 2020
• Est. completion date: December 22, 2021

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• 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 on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

2. 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.

3. Subjects must have completed all scheduled visits of previous study. Subjects can only enter this study after exiting previous study

4. 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.

5. Diagnosis of exudative age-related macular degeneration (AMD) in the study eye, as assessed by spectral domain optical coherence tomography (SD-OCT).

6. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing VA improvement in the study eye.

7. BCVA of 24 ETDRS 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 SD-OCT and fundus photography.

Exclusion Criteria:

• 1. 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

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• RBM-007
Intravitreal injection

Locations

Country	Name	City	State
United States	Raj K. Maturi, M.D., P.C.	Indianapolis	Indiana
United States	Valley Retina Institute	McAllen	Texas
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Retinal Medical Consultants 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	Month 4
Secondary	Visual Acuity - Categorical	Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline	Month 4
Secondary	Change From Baseline in Central Macular Subfield Thickness		Month 4