Abstract
Purpose :
The IBE-814 Intravitreal (IVT) Implant is a fully degradable, injectable, 30-gauge implant that delivers a sustained, low dose of dexamethasone without the use of a polymer carrier for at least 6 months. The RIPPLE-1 trial was designed to evaluate the safety, efficacy, and durability of the implant in subjects with diabetic macular edema (DME) or retinal vein occlusion (RVO) and to select the optimal drug dose for future studies.
Methods :
The RIPPLE-1 trial was a Phase 2, randomized, single-masked, multi-center, dose-ranging study of the IBE-814 IVT Implant. Treatment naïve and previously treated DME and RVO subjects were randomized to receive one (Low Dose, LD) or two (High Dose, HD) 70 μg implants at baseline. The key study endpoints were mean change in central subfield thickness (CST) and best-corrected visual acuity (BCVA) at 6 months, as well as safety endpoints throughout the study. Subjects were eligible for retreatment with the IBE-814 IVT Implant between 5 and 12 months, based on anatomical and functional criteria.
Results :
Sixty subjects in four cohorts were treated with the IBE-814 IVT Implant: RVO Low Dose (n=10), DME Low Dose (n=23), RVO High Dose (n=15), and DME High Dose (n=12). At the 6-month key efficacy endpoint, all cohorts demonstrated reduced CST, with mean (SE) thickness reductions from Baseline of -188 (60) μm (RVO LD), -68 (20) μm (DME LD), -148 (45) μm (RVO HD), and -94 (23) μm (DME HD). All cohorts showed improved or stable mean BCVA. At 6 months, the mean (SE) changes in BCVA from Baseline were +6.4 (3.9) letters (RVO LD), -1.9 (2.0) letters (DME LD), +5.5 (1.9) letters (RVO HD), and +8.7 (1.0) letters (DME HD). After one treatment with IBE-814, at least 60% of subjects in each cohort reached the 6-month visit without receiving additional treatment. The most common treatment-related adverse events were known steroid side-effects: elevated intraocular pressure and cataracts.
Conclusions :
The IBE-814 IVT Implant demonstrated sustained reductions in CST, with improved or stable BCVA, for at least 6 months in DME and RVO and has been well-tolerated to date. The results of the study will be presented along with efficacy and safety trends that will inform dose selection for future trials.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.