Trial Outcomes & Findings for 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 (NCT NCT04640272)

NCT ID: NCT04640272

Last Updated: 2023-06-08

Results Overview

Mean change in Best Corrected Visual Acuity from Baseline

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Month 4

Results posted on

2023-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	RBM-007 Injectable Solution intravitreal injection RBM-007: Intravitreal injection
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RBM-007 Injectable Solution intravitreal injection RBM-007: Intravitreal injection
Overall Study Subject moved out of area	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RBM-007 Injectable Solution n=22 Participants intravitreal injection RBM-007: Intravitreal injection
Age, Continuous	77.41 years STANDARD_DEVIATION 8.42 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	22 Participants n=99 Participants
Best corrected visual acuity	61.82 Letters seen on eye chart STANDARD_DEVIATION 14.47 • n=99 Participants
Central macular subfield thickness	438.64 microns STANDARD_DEVIATION 129.69 • n=99 Participants

PRIMARY outcome

Timeframe: Month 4

Mean change in Best Corrected Visual Acuity from Baseline

Outcome measures

Outcome measures
Measure	RBM-007 Injectable Solution n=22 Participants intravitreal injection RBM-007: Intravitreal injection
Visual Acuity - Continuous	-5.5 Letter seen on eye chart Standard Deviation 1.2

SECONDARY outcome

Timeframe: Month 4

Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline

Outcome measures

Outcome measures
Measure	RBM-007 Injectable Solution n=22 Participants intravitreal injection RBM-007: Intravitreal injection
Visual Acuity - Categorical	0 Participants

SECONDARY outcome

Timeframe: Month 4

Outcome measures

Outcome measures
Measure	RBM-007 Injectable Solution n=22 Participants intravitreal injection RBM-007: Intravitreal injection
Change From Baseline in Central Macular Subfield Thickness	55.9 Microns Standard Deviation 15.66

Adverse Events

RBM-007 Injectable Solution

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RBM-007 Injectable Solution n=22 participants at risk intravitreal injection RBM-007: Intravitreal injection
Infections and infestations COVID-19	4.5% 1/22 • Number of events 1 • Baseline through Month 4

Other adverse events

Other adverse events
Measure	RBM-007 Injectable Solution n=22 participants at risk intravitreal injection RBM-007: Intravitreal injection
Infections and infestations Infections and infestations	9.1% 2/22 • Number of events 2 • Baseline through Month 4

Additional Information

Dr. Yoshikazu Nakamura

Ribomic, Inc.

Phone: 81-3-3440-3303

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60