Progression of diabetic retinopathy severity after treatment with dexamethasone implant: a 24-month cohort study the ‘DR-Pro-DEX Study’
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Intravitreal anti-vascular endothelial growth factor agents have been shown to reduce diabetic retinopathy (DR) progression; data on the effects of intravitreal corticosteroids on modifying disease severity are limited. This study evaluates the long-term effect of intravitreal dexamethasone implant (DEX) on the severity and progression of non-proliferative DR (NPDR).
This was a retrospective cohort study. Sixty eyes from 60 consecutive patients with NPDR and diabetic macular edema (DME) treated with dexamethasone implant (DEX group) and 49 eyes from consecutive 49 patients without DME requiring observation only. Fundus angiography images from baseline and after 24 months were graded by two masked assessors into mild, moderate and severe NPDR and PDR, according to the ETDRS classification. Patients were followed up 1–3 and 4–6 months after each DEX implant. Re-treatment with DEX implant was on a pro re nata basis. Records were reviewed for performance of panretinal photocoagulation. Main outcome was as follows: change of DR ≥ 1 grade and progression to proliferative diabetic retinopathy (PDR).
Three eyes (5%) in the DEX group and 43 (87.8%) eyes in the control group progressed to PDR (P < 0.0001). Twenty-five eyes (41.7%) in the DEX group but none in the control group demonstrated an improvement in DR severity (P < 0.0001).
This study provides the first long-term evidence that DEX implant has the potential to not only delay progression of DR and PDR development, but may also improve DR severity over 24 months. Better understanding of the effects of corticosteroids will help guide its use in the treatment pathway of DR.
KeywordsDiabetic retinopathy Severity Progression Dexamethasone implant Panretinal photocoagulation
Anat Loewenstein is a consultant for Allergan. Matias Iglicki, Dinah Zur, Catharina Busch and Mali Okada receive travel support by Allergan.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
Institutional review board approval was obtained through the individual IRBs at the participating institutes for a retrospective consecutive chart review. The research adhered to the tenets of the Declaration of Helsinki.
- 1.Early Treatment Diabetic Retinopathy Study Research Group (1991) Grading diabetic retinopathy from stereoscopic color fundus photographs—an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic c Study Research Group. Ophthalmology 98:786–806CrossRefGoogle Scholar
- 7.Chaturvedi N, Porta M, Klein R et al (2008) Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials. Lancet 372:1394–1402. https://doi.org/10.1016/S0140-6736(08)61412-9 CrossRefPubMedGoogle Scholar
- 26.dell’Omo R, Semeraro F, Bamonte G et al (2013) Vitreous mediators in retinal hypoxic diseases. Mediat Inflamm 2013:935301Google Scholar
- 32.Bressler NM, Edwards AR, Beck RW et al (2009) Exploratory analysis of diabetic retinopathy progression through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with focal/grid photocoagulation. Arch Ophthalmol (Chicago, Ill 1960) 127:1566–1571CrossRefGoogle Scholar
- 38.Campochiaro PA, Brown DM, Pearson A et al (2011) Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 118(626–635):e2Google Scholar
- 40.Sivaprasad S, Prevost AT, Vasconcelos JC et al (2017) Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, n. Lancet 389:2193–2203. https://doi.org/10.1016/S0140-6736(17)31193-5 CrossRefPubMedGoogle Scholar