Exudative Age-related Macular Degeneration
Conditions
Brief 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.
Interventions
DRUGRBM-007
Intravitreal injection
Sponsors
Ribomic USA Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, non-comparative
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - Continuous | Month 4 | Mean change in Best Corrected Visual Acuity from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - Categorical | Month 4 | Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline |
| Change From Baseline in Central Macular Subfield Thickness | Month 4 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RBM-007 Injectable Solution intravitreal injection
RBM-007: Intravitreal injection | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject moved out of area | 1 |
Baseline characteristics
| Characteristic | RBM-007 Injectable Solution |
|---|---|
| Age, Continuous | 77.41 years STANDARD_DEVIATION 8.42 |
| Best corrected visual acuity | 61.82 Letters seen on eye chart STANDARD_DEVIATION 14.47 |
| Central macular subfield thickness | 438.64 microns STANDARD_DEVIATION 129.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 2 / 22 |
| serious Total, serious adverse events | 1 / 22 |
Outcome results
Primary
Visual Acuity - Continuous
Mean change in Best Corrected Visual Acuity from Baseline
Time frame: Month 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RBM-007 Injectable Solution | Visual Acuity - Continuous | -5.5 Letter seen on eye chart | Standard Deviation 1.2 |
Secondary
Change From Baseline in Central Macular Subfield Thickness
Time frame: Month 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RBM-007 Injectable Solution | Change From Baseline in Central Macular Subfield Thickness | 55.9 Microns | Standard Deviation 15.66 |
Secondary
Visual Acuity - Categorical
Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline
Time frame: Month 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RBM-007 Injectable Solution | Visual Acuity - Categorical | 0 Participants |