Phase 1/2 Open Label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)
Overview
- Phase
- Phase 1
- Intervention
- RBM-007 Injectable Solution
- Conditions
- Age-related Macular Degeneration
- Sponsor
- Ribomic USA Inc
- Enrollment
- 9
- Locations
- 3
- Primary Endpoint
- Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.
Detailed Description
Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- •At Screening Visit, subjects must meet all the following inclusion criteria:
- •Must have had prior treatment in the study eye with any intravitreal vasoactive endothelial growth factor (VEGF) medication (at least 3 anti-VEGF) treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage.
- •Best corrected visual acuity of 65 to 20 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (20/50 to 20/400) in the study eye.
- •Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by optical coherence tomography in the study eye, with a minimum of 300 µm within the central subfield.
- •Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage and ≤50% subretinal fibrosis and ≤50% retinal pigment epithelial atrophy in the study eye.
- •Reasonably clear media and reasonable fixation ability in the study eye to allow for good quality tomography and fundus photography.
- •At Baseline Visit (Day 0), subjects must meet all the following inclusion criteria:
- •Best Corrected Visual Acuity (BCVA) of 65 to 20 ETDRS letters (20/50 to 20/400) in the study eye.
- •Presence of significant subretinal and/or intraretinal fluid secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield.
Exclusion Criteria
- •Ocular exclusion criteria:
- •BCVA better than 65 ETDRS letters (20/50) in the study eye.
- •BCVA worse than 20 ETDRS letters (20/400) in study eye.
- •Fellow eye BCVA worse than 35 ETDRS letters (20/200).
- •Use of any of the following treatments to the study eye:
- •Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) in the study eye within the past 4 weeks or less prior to Baseline Visit and RBM-007 injection.
- •Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit (Day 0) and throughout the study;
- •Fluocinolone acetonide intravitreal implant, within 12 months prior to Baseline Visit (Day 0) and throughout the study;
- •Visudyne® (verteporfin) photodynamic therapy, within 3 months prior to Baseline Visit (Day 0) and throughout the study.
- •Uncontrolled or advanced glaucoma, defined by an intraocular pressure (IOP) of \>21 mmHg or cup/disc ratio \> 0.8 while on medical therapy, or chronic ocular hypotony (\<6 mmHg) in the study eye.
Arms & Interventions
RBM-007 Injectable Solution - 1.0 mg
No additional information.
Intervention: RBM-007 Injectable Solution
RBM-007 Injectable Solution - 0.2 mg
No additional information.
Intervention: RBM-007 Injectable Solution
RBM-007 Injectable Solution - 2.0 mg
No additional information.
Intervention: RBM-007 Injectable Solution
Outcomes
Primary Outcomes
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
Time Frame: Day 56
Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
Time Frame: Day 56
Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Secondary Outcomes
- Ocular Tolerability as Assessed by Number and Nature of Adverse Events(Day 56)