TOFU: A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sham + RBM-007 Sham + RBM-007 intravitreal injection |
Drug: RBM-007 Injectable Solution
RBM-007 Injectable Solution
Drug: Sham
Sham intravitreal injection
|
| Experimental: RBM-007 + Aflibercept RBM-007 + Aflibercept intravitreal injection |
Drug: RBM-007 Injectable Solution
RBM-007 Injectable Solution
Drug: Aflibercept
EYLEA® (aflibercept) Injection, for Intravitreal Use
|
| Active Comparator: Sham + Aflibercept Sham + Aflibercept intravitreal injection |
Drug: Aflibercept
EYLEA® (aflibercept) Injection, for Intravitreal Use
Drug: Sham
Sham intravitreal injection
|
Outcome Measures
Primary Outcome Measures
- Visual acuity - continuous [Week 16]
Mean change in Best Corrected Visual Acuity from Baseline
Secondary Outcome Measures
- Visual acuity - categorical [Week 16]
Proportion of patients gaining more than 15 letters as measured by Best Corrected Visual Acuity from Baseline
- Macular thickness change [Week 16]
Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography
- Macular volume change [Week 16]
Change from Baseline in macular volume by spectral domain optical coherence tomography
- Fibrosis change [Week 16]
Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography
- Safety - Ocular [Week 20]
Ocular examination (biomicroscopy and ophthalmoscopy)
- Safety - Systemic - Heart rate [Week 20]
Change in heart rate (beats per minute)
- Safety - Systemic - Blood pressure [Week 20]
Change in systolic and diastolic blood pressure (millimeters of mercury)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide signed written informed consent.
-
Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures.
-
Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography.
-
Presence of macular edema or subretinal fluid.
-
Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
-
Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
-
Visual acuity of 24 letters (20/320) or better in the fellow eye.
-
Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography
Exclusion Criteria:
- Ocular:
-
Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
-
Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
-
Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
-
Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
-
Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retinal Research Institute, LLC | Phoenix | Arizona | United States | 85053 |
| 2 | Retinal Consultants Medical Group | Sacramento | California | United States | 95841 |
| 3 | Bay Area Retina Associates | Walnut Creek | California | United States | 94704 |
| 4 | Advanced Research, LLC | Coral Springs | Florida | United States | 33067 |
| 5 | Georgia Retina, P.C. | Marietta | Georgia | United States | 30060 |
| 6 | Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | United States | 46290 |
| 7 | Valley Retina Institute, PA | McAllen | Texas | United States | 78503 |
| 8 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Ribomic USA Inc
Investigators
- Study Director: Padma Bezwada, Ph.D., RIBOMIC USA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RBM 007-002