Trial Outcomes & Findings for A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration (NCT NCT04200248)
NCT ID: NCT04200248
Last Updated: 2023-06-08
Results Overview
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Week 16
Results posted on
2023-06-08
Participant Flow
Participant milestones
| Measure |
Sham + RBM-007
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
31
|
|
Overall Study
COMPLETED
|
29
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Sham + RBM-007
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Overall Study
Personal reasons
|
0
|
0
|
1
|
|
Overall Study
Discontinued prior to treatment
|
3
|
3
|
2
|
Baseline Characteristics
Data presented for population treated (8 subjects discontinued before treatment)
Baseline characteristics by cohort
| Measure |
Sham + RBM-007
n=32 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=31 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=31 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=32 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=94 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=32 Participants
|
28 Participants
n=31 Participants
|
31 Participants
n=31 Participants
|
90 Participants
n=94 Participants
|
|
Age, Continuous
|
80.41 years
STANDARD_DEVIATION 7.47 • n=32 Participants
|
75.32 years
STANDARD_DEVIATION 8.64 • n=31 Participants
|
78.52 years
STANDARD_DEVIATION 7.07 • n=31 Participants
|
78.1 years
STANDARD_DEVIATION 7.96 • n=94 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=32 Participants
|
15 Participants
n=31 Participants
|
18 Participants
n=31 Participants
|
54 Participants
n=94 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=32 Participants
|
16 Participants
n=31 Participants
|
13 Participants
n=31 Participants
|
40 Participants
n=94 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=32 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=94 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=32 Participants
|
29 Participants
n=31 Participants
|
29 Participants
n=31 Participants
|
88 Participants
n=94 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=32 Participants
|
31 Participants
n=31 Participants
|
31 Participants
n=31 Participants
|
92 Participants
n=94 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=94 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
94 participants
n=94 Participants
|
|
Best corrected visual acuity
|
60.24 Letter seen
STANDARD_DEVIATION 13.00 • n=29 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
66.71 Letter seen
STANDARD_DEVIATION 10.81 • n=28 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
61.52 Letter seen
STANDARD_DEVIATION 13.83 • n=29 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
62.78 Letter seen
STANDARD_DEVIATION 13.13 • n=86 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
|
Central subfield thickness (macula)
|
452.07 Microns
STANDARD_DEVIATION 138.24 • n=29 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
398.04 Microns
STANDARD_DEVIATION 124.01 • n=28 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
437.55 Microns
STANDARD_DEVIATION 129.34 • n=29 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
429.58 Microns
STANDARD_DEVIATION 131.20 • n=86 Participants • Data presented for population treated (8 subjects discontinued before treatment)
|
|
Macular volume
|
9.03 mm^3
STANDARD_DEVIATION 0.23 • n=29 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
8.84 mm^3
STANDARD_DEVIATION 0.23 • n=28 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
9.00 mm^3
STANDARD_DEVIATION 0.23 • n=29 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
8.96 mm^3
STANDARD_DEVIATION 0.23 • n=86 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
|
Fibrosis
|
27 Participants
n=29 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
27 Participants
n=28 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
28 Participants
n=29 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
82 Participants
n=86 Participants • Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment)
|
PRIMARY outcome
Timeframe: Week 16Population: Data presented for population treated (8 subjects discontinued before treatment)
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
Outcome measures
| Measure |
Sham + RBM-007
n=29 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=28 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Visual Acuity - Continuous
|
-6.1 Letters seen
Standard Error 1.70
|
-1.6 Letters seen
Standard Error 1.75
|
2.4 Letters seen
Standard Error 1.69
|
SECONDARY outcome
Timeframe: Week 16Population: Data presented for population treated (8 subjects discontinued before treatment)
Percentage of patients gaining \>= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16
Outcome measures
| Measure |
Sham + RBM-007
n=29 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=28 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Visual Acuity - Categorical
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Data presented for population treated (8 subjects discontinued before treatment)
Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16
Outcome measures
| Measure |
Sham + RBM-007
n=29 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=28 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Macular Thickness Change
|
36.5 microns
Standard Error 12.60
|
-5.8 microns
Standard Error 12.89
|
-16.1 microns
Standard Error 12.55
|
SECONDARY outcome
Timeframe: Week 16Population: Data presented for population treated (8 subjects discontinued before treatment)
Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16
Outcome measures
| Measure |
Sham + RBM-007
n=29 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=28 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Macular Volume Change
|
0.748 mm^3
Standard Error 0.120
|
0.0095 mm^3
Standard Error 0.124
|
-0.010 mm^3
Standard Error 0.120
|
SECONDARY outcome
Timeframe: Week 16Population: Data presented for population treated (8 subjects discontinued before treatment)
Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16
Outcome measures
| Measure |
Sham + RBM-007
n=29 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=28 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Fibrosis Change
Better
|
3 Participants
|
8 Participants
|
9 Participants
|
|
Fibrosis Change
Not better
|
26 Participants
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Week 20Population: Data presented for population treated (8 subjects discontinued before treatment)
Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities
Outcome measures
| Measure |
Sham + RBM-007
n=28 Participants
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=29 Participants
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 Participants
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Safety - Ocular
Additional corneal abnormalities
|
9 Participants
|
11 Participants
|
10 Participants
|
|
Safety - Ocular
No additional corneal abnormalities
|
19 Participants
|
18 Participants
|
19 Participants
|
Adverse Events
Sham + RBM-007
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
RBM-007 + Aflibercept
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Sham + Aflibercept
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham + RBM-007
n=28 participants at risk
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=29 participants at risk
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 participants at risk
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Eye disorders
Iritis
|
7.1%
2/28 • Number of events 2 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
|
Eye disorders
Vitritis
|
7.1%
2/28 • Number of events 2 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
|
Eye disorders
Eye pain
|
3.6%
1/28 • Number of events 1 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/28 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/28 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/28 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
Other adverse events
| Measure |
Sham + RBM-007
n=28 participants at risk
Sham + RBM-007 intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Sham: Sham intravitreal injection
|
RBM-007 + Aflibercept
n=29 participants at risk
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
|
Sham + Aflibercept
n=29 participants at risk
Sham + Aflibercept intravitreal injection
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham: Sham intravitreal injection
|
|---|---|---|---|
|
Eye disorders
Eye disorders
|
46.4%
13/28 • Number of events 13 • 20 Weeks
|
51.7%
15/29 • Number of events 15 • 20 Weeks
|
27.6%
8/29 • Number of events 8 • 20 Weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
17.9%
5/28 • Number of events 5 • 20 Weeks
|
20.7%
6/29 • Number of events 6 • 20 Weeks
|
10.3%
3/29 • Number of events 3 • 20 Weeks
|
|
Eye disorders
Dry eye
|
14.3%
4/28 • Number of events 4 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
|
Eye disorders
Eye irritation
|
7.1%
2/28 • Number of events 2 • 20 Weeks
|
6.9%
2/29 • Number of events 2 • 20 Weeks
|
3.4%
1/29 • Number of events 1 • 20 Weeks
|
|
Eye disorders
Eye pain
|
7.1%
2/28 • Number of events 2 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
0.00%
0/29 • 20 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60