Trial Outcomes & Findings for RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration (NCT NCT04895293)

NCT ID: NCT04895293

Last Updated: 2023-04-12

Results Overview

Central subfield thickness on optical coherence tomography

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-04-12

Participant Flow

Participant milestones

Measure	RBM-007 Injectable Solution - 2.0 mg Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration

Baseline characteristics by cohort

Measure	RBM-007 Injectable Solution - 2.0 mg n=5 Participants Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Visual Acuity	66.6 Letters seen on eye chart n=5 Participants
Central subfield thickness	422.8 Microns n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Central subfield thickness on optical coherence tomography

Outcome measures

Measure	RBM-007 Injectable Solution - 2.0 mg n=5 Participants Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution
Macular Edema	416 Microns Interval 257.0 to 648.0

SECONDARY outcome

Timeframe: 3 Months

Change from Baseline in Best Corrected Visual Acuity

Outcome measures

Measure	RBM-007 Injectable Solution - 2.0 mg n=5 Participants Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution
Visual Acuity	60 Letters seen on eye chart Interval 28.0 to 77.0

Adverse Events

RBM-007 Injectable Solution - 2.0 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	RBM-007 Injectable Solution - 2.0 mg n=5 participants at risk Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution
Respiratory, thoracic and mediastinal disorders Positive COVID test	20.0% 1/5 • Number of events 1 • 3 months All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.
Eye disorders Subretinal hemorrhage	20.0% 1/5 • Number of events 1 • 3 months All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.
Cardiac disorders Myocardial infarction (mild)	20.0% 1/5 • Number of events 1 • 3 months All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.
Gastrointestinal disorders Diarrhea (severe)	20.0% 1/5 • Number of events 1 • 3 months All adverse events and serious adverse events were continually assessed throughout the study. The investigator assessed safety throughout the study to determine appropriateness of continuing dosing and enrollment.

Additional Information

Raj K. Maturi, M.D.

Midwest Eye Institute

Phone: 317-817-1423

Email: maturi.md@midwesteye.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place