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 study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBM-007 Injectable Solution - 2.0 mg | Experimental | Single intravitreal injection in study eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBM-007 Injectable Solution | Drug | Sterile solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular Edema | Central subfield thickness on optical coherence tomography | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Change from Baseline in Best Corrected Visual Acuity | 3 Months |
Not provided
Inclusion Criteria:
• General Inclusion Criteria:
Male or female patients, 50 years of age or older at baseline
Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.
• Ocular Inclusion Criteria:
Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
Presence of choroidal neovascularization secondary to AMD
Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.
Exclusion Criteria:
• General Exclusion Criteria:
Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
Participation in any investigational drug or device study within 30 days prior to baseline
History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• Ocular Exclusion Criteria:
Active ocular or periocular infections, malignancy
Aphakia
History of pars plana vitrectomy in the study eye
History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
History of significant ocular disease other than exudative AMD that may confound results
Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raj K. Maturi, M.D. | Midwest Eye Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RBM-007 Injectable Solution - 2.0 mg | Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RBM-007 Injectable Solution - 2.0 mg | Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Macular Edema | Central subfield thickness on optical coherence tomography | Posted | Mean | Full Range | Microns | 3 months |
|
|
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.
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 - 2.0 mg | Single intravitreal injection in study eye RBM-007 Injectable Solution: Sterile solution |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Positive COVID test | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj K. Maturi, M.D. | Midwest Eye Institute | 317-817-1423 | maturi.md@midwesteye.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2021 | Mar 20, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
All subjects receive the study treatment
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Visual Acuity | Mean | Full Range | Letters seen on eye chart |
|
| Central subfield thickness | Mean | Full Range | Microns |
|
|
| Secondary | Visual Acuity | Change from Baseline in Best Corrected Visual Acuity | Posted | Mean | Full Range | Letters seen on eye chart | 3 Months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Subretinal hemorrhage | Eye disorders | Non-systematic Assessment |
|
| Myocardial infarction (mild) | Cardiac disorders | Non-systematic Assessment |
|
| Diarrhea (severe) | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided