Trial Outcomes & Findings for RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (NCT NCT03633084)
NCT ID: NCT03633084
Last Updated: 2021-01-05
Results Overview
Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Day 56
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
RBM-007 Injectable Solution - 0.2 mg
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
RBM-007 Injectable Solution - 0.2 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ocular safety as assessed using biomicroscopy to investigate ocular tolerability
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ocular safety as assessed using ophthalmoscopy to investigate ocular tolerability
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Customized
Range
|
87 years
n=93 Participants
|
80 years
n=4 Participants
|
86 years
n=27 Participants
|
86 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 56Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Outcome measures
| Measure |
RBM-007 Injectable Solution - 0.2 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
|---|---|---|---|
|
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 56Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Outcome measures
| Measure |
RBM-007 Injectable Solution - 0.2 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
|---|---|---|---|
|
Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 56Adverse events (ocular or non-ocular)
Outcome measures
| Measure |
RBM-007 Injectable Solution - 0.2 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
n=3 Participants
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
|---|---|---|---|
|
Ocular Tolerability as Assessed by Number and Nature of Adverse Events
|
1 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
RBM-007 Injectable Solution - 0.2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RBM-007 Injectable Solution - 1.0 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RBM-007 Injectable Solution - 2.0 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RBM-007 Injectable Solution - 0.2 mg
n=3 participants at risk
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 1.0 mg
n=3 participants at risk
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
RBM-007 Injectable Solution - 2.0 mg
n=3 participants at risk
No additional information.
RBM-007 Injectable Solution: (No additional description)
|
|---|---|---|---|
|
Eye disorders
Subconjunctival Hemorrhage
|
0.00%
0/3 • 56 days
|
33.3%
1/3 • Number of events 1 • 56 days
|
33.3%
1/3 • Number of events 1 • 56 days
|
|
Eye disorders
Mild local irritation
|
33.3%
1/3 • Number of events 1 • 56 days
|
0.00%
0/3 • 56 days
|
0.00%
0/3 • 56 days
|
|
Eye disorders
Iritis
|
0.00%
0/3 • 56 days
|
0.00%
0/3 • 56 days
|
33.3%
1/3 • Number of events 1 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Fall, leg injury, and sequelae
|
33.3%
1/3 • Number of events 3 • 56 days
|
0.00%
0/3 • 56 days
|
0.00%
0/3 • 56 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3 • 56 days
|
33.3%
1/3 • Number of events 1 • 56 days
|
0.00%
0/3 • 56 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER