Original articleFluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: A 3-Year Multicenter, Randomized, Controlled Clinical Trial
Section snippets
Study Design
This was a 4-year, prospective, multicenter, randomized, evaluator-masked, parallel-group, controlled clinical trial in eyes with DME conducted at 23 study centers in the United States (a list of the investigators and study centers is available online at http://aaojournal.org). The study protocol (ClinicalTrials.gov identifier: NCT00502541) was approved by the institutional review board/ethics committee at each study site. The study was conducted in accordance with the Declaration of Helsinki
Results
Patient enrollment began in September 2001 and completed by 2003. The patient disposition and demographic characteristics for the 196 eyes enrolled in the study are presented in Table 2 (available online at http://aaojournal.org). Demographic characteristics were similar between the implant and SOC groups. The percentage of patients dependent on insulin at baseline was 70.1% (89 of 127) in the implant group and 62.3% (43 of 69) in the SOC group.
Discussion
This study was conducted to determine the efficacy and safety of the FA intravitreal implant in the treatment of eyes with persistent or recurrent DME. The primary efficacy outcome was the percentage of eyes with a ≥15-letter increase in VA at 6 months. VA increases of ≥3 lines were observed in 16.8% of implanted eyes compared with 1.4% of SOC eyes at 6 months (P=0.0012), thus meeting the primary endpoint of the study. Significant improvement in VA was also observed in the implant group at 9,
References (28)
The potential role of PKC beta in diabetic retinopathy and macular edema
Surv Ophthalmol
(2002)- et al.
Intravitreal triamcinolone for refractory diabetic macular edema
Ophthalmology
(2002) - et al.
Primary intravitreal bevacizumab (Avastin) for diabetic macular edema: results from the Pan-American Collaborative Retina Study Group at 6-month follow-up
Ophthalmology
(2007) - et al.
A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema
Ophthalmology
(2006) - et al.
Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study
Ophthalmology
(2006) - et al.
Change in visual acuity associated with cataract surgeryThe Beaver Dam Eye Study
Ophthalmology
(1996) - et al.
Budesonide reduces vascular endothelial growth factor secretion and expression in airway (Calu-1) and alveolar (A549) epithelial cells
Eur J Pharmacol
(2001) - et al.
The safety profile of long-term, high-dose intraocular corticosteroid delivery
Am J Ophthalmol
(2005) - et al.
Intravitreal triamcinolone-induced elevated intraocular pressure is associated with the development of posterior subcapsular cataract
Ophthalmology
(2005) - et al.
An extension of the Early Treatment Diabetic Retinopathy Study (ETDRS) system for grading of diabetic macular edema in the Astemizole Retinopathy Trial
Curr Eye Res
(2006)
Effect of laser photocoagulation treatment for diabetic macular oedema on patient's vision-related quality of life
Curr Eye Res
Photocoagulation for diabetic macular edemaEarly Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group
Arch Ophthalmol
Emerging therapies for the treatment of neovascular age-related macular degeneration and diabetic macular edema
BioDrugs
A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema
Ophthalmology
Cited by (180)
From randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema
2023, Progress in Retinal and Eye ResearchVEGFR1 signaling in retinal angiogenesis and microinflammation
2021, Progress in Retinal and Eye ResearchCitation Excerpt :Indeed, one of the most compelling arguments for an involvement of inflammation in DR is the well-established potency of corticosteroids in the treatment of DME (Rittiphairoj et al., 2020; Whitcup et al., 2018; Wykoff, 2017). Interestingly, there is evidence that benefits of steroid treatment are not limited to just edema but may also slow down development of PDR and overall progression of DR (Pearson et al., 2011; Querques et al., 2017; Wykoff et al., 2017), suggesting that inflammatory mechanisms (such as persistent low-grade inflammation) make a causal contribution to DR (Kinuthia et al., 2020). This is consistent with a large collection of clinical studies showing increased ocular levels of inflammatory mediators, including IL-1β, IL-6, IL-8, TNF-α, and CCL2, in NPDR, DME and PDR (Bolinger and Antonetti, 2016; Chernykh et al., 2015; Funatsu et al., 2012; Kovacs et al., 2015; Mao and Yan, 2014; Mesquida et al., 2019; Rubsam et al., 2018; Tang and Kern, 2011; Wykoff, 2017; Zhou et al., 2012).
Recent trends in drug-delivery systems for the treatment of diabetic retinopathy and associated fibrosis
2021, Advanced Drug Delivery ReviewsCitation Excerpt :In comparison with the standard of care, the implant significantly improved visual acuity and the diabetic retinopathy severity score (DRSS) and reduced macular retinal thickening [233]. Adverse effects included cataract progression and elevated intraocular pressure [233]. Iluvien® is a cylindrical implant made of polyimide that is approved for the treatment of DMO.
A Review on Diabetic Retinopathy
2024, Current Diabetes ReviewsIncidence and treatment approach of intraocular pressure elevation after various types of local steroids for retinal diseases
2023, Graefe's Archive for Clinical and Experimental Ophthalmology
Manuscript no. 2010-224.
A list of principle investigators and board members is available at http://aaojournal.org.
Financial Disclosure(s): The authors have made the following disclosures:
At the time the study was conducted, Dr. Brian Levy, and Dr. Timothy Comstock were employees of Bausch & Lomb Inc., Rochester, New York, the sponsor of this study. Dr. Dean Eliott, Dr. Michael Ip, Dr. David Callanan, Dr. Lawrence Morse and Dr. Eric Mann had no proprietary interest in the firm. Dr. Paul Ashton is the CEO of pSivida, the company that invented Retisert, and is one of the inventors listed on the patent; Dr. Andrew Pearson had a financial interest in the product. Dr. Dean Eliott was a pSivida stockholder, and he is an ad hoc consultant for Alcon, Allergan, Bausch & Lomb, Genentech, and Glaukos. None of the other investigators had a proprietary interest in fluocinolone acetonide intravitreal implant.
Financial support for this research was provided by Bausch & Lomb Incorporated, Rochester, New York. The sponsor participated in the design of the study; conducting the study; data collection, management, and analysis; interpretation of the data; and preparation, review, and approval of the manuscript.