Phase 2
N=94
A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration
Exudative Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04200248 ↗Enrolled (actual)
94
Serious AEs
5.8%
Results posted
Jun 2023
Primary outcome: Primary: Visual Acuity - Continuous — -6.1; -1.6; 2.4 Letters seen
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RBM-007 Injectable Solution (Drug); Aflibercept (Drug); Sham (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Ribomic USA Inc
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity - Continuous |
-6.1; -1.6; 2.4 | — |
| SECONDARY Visual Acuity - Categorical |
0; 0; 2 | — |
| SECONDARY Macular Thickness Change |
36.5; -5.8; -16.1 | — |
| SECONDARY Macular Volume Change |
0.748; 0.0095; -0.010 | — |
| SECONDARY Fibrosis Change |
3; 8; 9; 26; 20; 20 | — |
| SECONDARY Safety - Ocular |
9; 11; 10; 19; 18; 19 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04200248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.