Abstract
Purpose :
Abnormalities of the vitreoretinal interface can reduce the effectiveness of intravitreal therapies. The ILUVIT study aimed to measure intravitreal inflammatory and angiogenic cytokine levels prior to and following the intravitreal injection of the FAc implant. Here we also assess the concurrent changes in the vitreoretinal interface and retinal thickness.
Methods :
The single center phase IV investigator initiated ILUVIT study was conducted at the University of Frankfurt in Germany and approved by BfARM (EudraCT-Number: 2016-004488-38). It is a study to assess cytokine and chemokine expression patterns in 12 patient eyes with diabetic macula edema (DME), partial vitrectomy (pPPV) was performed prior to (month 0) and following therapy (month 1 and 6) with a single FAc implant and changes in the vitreoretinal interface (using OCT and B-scan ultrasonography) as well as changes in central (CRT) and average (ART) retinal thickness were measured. Exploratory analysis focused on outcomes based on the presence (n=7) or absence (n=5) of vitreoretinal traction.
Results :
When divided based on the presence of vitreoretinal traction, the starting CRT was higher (468±106 µm vs. 326±173 µm [presence vs. absence]). During the study the majority (86%) of patients eyes with initial vitreoretinal traction developed a PVD after performing pPPV. The combination of PVD and the FAc implant led to significant reductions in CRT (-134.43 µm, p=0.0005) and ART (-39.08 µm, p= 0.01). In contrast, the absence of vitreoretinal traction led to pronounced changes in CRT (-65.4 µm, p=0.24) and ART (-35.62 µm, p=0.165).
Analyses of cytokine and chemokine expression showed the FAc implant led to consistent changes (i.e. >20% change from baseline) in IP-10, MCP-1, and CD-54 in both groups, but not for IL-6, IL-8, VEGF and PIGF, where changes (>20% from baseline) were only observed in the absence of vitreoretinal traction at baseline.
Conclusions :
In this exploratory analysis, pPPV, which leads to partial reduction of vitreous volume and separation from the retinal surface, positively affected the course of DME in the patients studied.
This is a 2020 ARVO Annual Meeting abstract.