Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBM-007 injectable solution | Experimental | intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBM-007 | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Continuous | Mean change in Best Corrected Visual Acuity from Baseline | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Categorical | Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline | Month 4 |
| Change From Baseline in Central Macular Subfield Thickness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Padma Bezwada, PhD | Ribomic USA Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85053 | United States | ||
| Retinal Medical Consultants Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RBM-007 Injectable Solution | intravitreal injection RBM-007: Intravitreal injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | Mar 28, 2023 |
Not provided
Not provided
Open-label, non-comparative
Not provided
Not provided
Not provided
Not provided
| Month 4 |
| Sacramento |
| California |
| 95841 |
| United States |
| Bay Area Retina Associates | Walnut Creek | California | 94704 | United States |
| Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | 46290 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RBM-007 Injectable Solution | intravitreal injection RBM-007: Intravitreal injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Best corrected visual acuity | Mean | Standard Deviation | Letters seen on eye chart |
| |||||||||||||||||
| Central macular subfield thickness | Mean | Standard Deviation | microns |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity - Continuous | Mean change in Best Corrected Visual Acuity from Baseline | Posted | Mean | Standard Deviation | Letter seen on eye chart | Month 4 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Visual Acuity - Categorical | Percentage of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline | Posted | Count of Participants | Participants | Month 4 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Macular Subfield Thickness | Posted | Mean | Standard Deviation | Microns | Month 4 |
|
|
|
Baseline through Month 4
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RBM-007 Injectable Solution | intravitreal injection RBM-007: Intravitreal injection | 0 | 22 | 1 | 22 | 2 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment | COVID-19 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoshikazu Nakamura | Ribomic, Inc. | 81-3-3440-3303 | yoshi@ribomic.com |
| Prot_000.pdf |
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|