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This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham + RBM-007 | Experimental | Sham + RBM-007 intravitreal injection |
|
| RBM-007 + Aflibercept | Experimental | RBM-007 + Aflibercept intravitreal injection |
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| Sham + Aflibercept | Active Comparator | Sham + Aflibercept intravitreal injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBM-007 Injectable Solution | Drug | RBM-007 Injectable Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Continuous | Mean change in Best Corrected Visual Acuity from Baseline to Week 16 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Categorical | Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16 | Week 16 |
| Macular Thickness Change | Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
Ocular:
Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye.
Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study
History of vitrectomy in the study eye.
Need for ocular surgery in the study eye during the course of the study.
YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.
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| Name | Affiliation | Role |
|---|---|---|
| Padma Bezwada, Ph.D. | RIBOMIC USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85053 | United States | ||
| Retinal Consultants Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham + RBM-007 | Sham + RBM-007 intravitreal injection RBM-007 Injectable Solution: RBM-007 Injectable Solution Sham: Sham intravitreal injection |
| FG001 | RBM-007 + Aflibercept |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2019 | Mar 27, 2023 |
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| Aflibercept | Drug | EYLEA® (aflibercept) Injection, for Intravitreal Use |
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| Sham | Drug | Sham intravitreal injection |
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| Week 16 |
| Macular Volume Change | Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16 | Week 16 |
| Fibrosis Change | Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16 | Week 16 |
| Safety - Ocular | Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities | Week 20 |
| Sacramento |
| California |
| 95841 |
| United States |
| Bay Area Retina Associates | Walnut Creek | California | 94704 | United States |
| Advanced Research, LLC | Coral Springs | Florida | 33067 | United States |
| Georgia Retina, P.C. | Marietta | Georgia | 30060 | United States |
| Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | 46290 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
RBM-007 + Aflibercept intravitreal injection
RBM-007 Injectable Solution: RBM-007 Injectable Solution
Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use
| FG002 | Sham + Aflibercept | Sham + Aflibercept intravitreal injection Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use Sham: Sham intravitreal injection |
| COMPLETED |
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| NOT COMPLETED |
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Intent to treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham + RBM-007 | Sham + RBM-007 intravitreal injection RBM-007 Injectable Solution: RBM-007 Injectable Solution Sham: Sham intravitreal injection |
| BG001 | RBM-007 + Aflibercept | RBM-007 + Aflibercept intravitreal injection RBM-007 Injectable Solution: RBM-007 Injectable Solution Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use |
| BG002 | Sham + Aflibercept | Sham + Aflibercept intravitreal injection Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use Sham: Sham intravitreal injection |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Best corrected visual acuity | Data presented for population treated (8 subjects discontinued before treatment) | Mean | Standard Deviation | Letter seen |
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| Central subfield thickness (macula) | Data presented for population treated (8 subjects discontinued before treatment) | Mean | Standard Deviation | Microns |
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| Macular volume | Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment) | Mean | Standard Deviation | mm^3 |
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| Fibrosis | Number of subjects with fibrosis at baseline | Measure Analysis Population Description: Data presented for population treated (8 subjects discontinued before treatment) | Count of Participants | Participants |
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| 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 to Week 16 | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Mean | Standard Error | Letters seen | Week 16 |
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| Secondary | Visual Acuity - Categorical | Percentage of patients gaining >= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16 | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Count of Participants | Participants | Week 16 |
|
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| Secondary | Macular Thickness Change | Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16 | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Mean | Standard Error | microns | Week 16 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Macular Volume Change | Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16 | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Mean | Standard Error | mm^3 | Week 16 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Fibrosis Change | Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16 | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Safety - Ocular | Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities | Data presented for population treated (8 subjects discontinued before treatment) | Posted | Count of Participants | Participants | Week 20 |
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|
20 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham + RBM-007 | Sham + RBM-007 intravitreal injection RBM-007 Injectable Solution: RBM-007 Injectable Solution Sham: Sham intravitreal injection | 0 | 28 | 2 | 28 | 15 | 28 |
| EG001 | RBM-007 + Aflibercept | RBM-007 + Aflibercept intravitreal injection RBM-007 Injectable Solution: RBM-007 Injectable Solution Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use | 0 | 29 | 2 | 29 | 17 | 29 |
| EG002 | Sham + Aflibercept | Sham + Aflibercept intravitreal injection Aflibercept: EYLEA® (aflibercept) Injection, for Intravitreal Use Sham: Sham intravitreal injection | 0 | 29 | 1 | 29 | 8 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iritis | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Vitritis | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Neovascular age-related macular degeneration | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Endophthalmitis | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | MedDRA (23.0) | Non-systematic Assessment | Study eye |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (23.0) | Non-systematic Assessment | Study eye |
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| Dry eye | Eye disorders | MedDRA (23.0) | Non-systematic Assessment | Study Eye |
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| Eye irritation | Eye disorders | MedDRA (23.0) | Non-systematic Assessment | Study eye |
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| Eye pain | Eye disorders | MedDRA (23.0) | Non-systematic Assessment | Study eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yoshikazu Nakamura | Ribomic, Inc. | 81-3-3440-3303 | yoshi@ribomic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2021 | Mar 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004487 | Edema |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008679 | Metaplasia |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| C005703 | salicylhydroxamic acid |
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