Abstract
Purpose :
The IBE-814 Intravitreal (IVT) Implant is a fully degradable, 30-gauge implant that delivers a sustained, low dose of dexamethasone for at least 6 months without the use of a polymer carrier. The extended delivery of drug has the potential to reduce treatment frequency for patients with macular edema. This analysis of the RIPPLE-1 study data assesses the impact of the IBE-814 IVT Implant on injection burden.
Methods :
In the RIPPLE-1 study, treatment naïve and previously treated subjects with diabetic macular edema (DME) and retinal vein occlusion (RVO) were randomized to receive one (Low Dose, LD) or two (High Dose, HD) 70 µg implants at baseline. Subjects were eligible for retreatment with the same dose of the IBE-814 IVT Implant between 5 and 12 months, based on anatomical and functional criteria. The analysis presented here examines study data from the RIPPLE-1 trial as well as historical treatment data from previously treated study subjects who consented to participate in this project.
Results :
Sixty subjects were enrolled in the RIPPLE-1 study in four cohorts: RVO Low Dose (n=10), DME Low Dose (n=23), RVO High Dose (n=15), and DME High Dose (n=12). After a single treatment with IBE-814, 60% (RVO LD), 65% (DME LD), 80% (RVO HD), and 92% (DME HD) of subjects reached the 6-month visit without requiring any additional therapy. Out of 32 prior treated subjects, 26 consented to participate in the historical data analysis (n=4 RVO LD, n=8 DME LD, n=10 RVO HD, n=4 DME HD). Among those subjects, the burden of treatment was reduced by 67% (RVO LD), 51% (DME LD), 86% (RVO HD), and 80% (DME HD) over 12 months of study follow-up, relative to the year prior to study enrollment.
Conclusions :
The IBE-814 IVT Implant provided a sustained treatment effect of at least 6 months in the majority of RIPPLE-1 study subjects. Among previously treated subjects, the implant reduced the burden of treatment by at least 50% in the Low Dose cohorts and at least 80% in the High Dose cohorts.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.