Intravitreal Implants for Treatment of Diabetic Macular Edema in Vitrectomized Patients


ABSTRACT

Purpose:

To evaluate and compare the functional, anatomical and safety response after the long-acting intravitreal sustained release fluocinolone acetonide (FAc) implant (0.2 µg/day, ILUVIEN®) and dexamethasone implant (Ozurdex® 0.7 mg) in the treatment of diabetic macular edema (DME) in vitrectomized eyes.

Setting:

Department of Ophthalmology of a tertiary referral center in Oporto, Portugal – Centro Hospitalar Universitário do Porto

Methods:

Retrospective, comparative, analysis of 40 eyes of 33 patients with chronic DME. Patients were divided in two groups: 24 vitrectomized eyes of 21 patients received intravitreal injection of 0.2 µg/day FAc implant (group 1) and 16 vitrectomized eyes of 12 patients received intravitreal injection of 0.7-mg dexamethasone implant (group 2). Patients\’ demographic data, best-corrected visual acuity (BCVA) measured with an ETDRS chart, duration of DME, number of intravitreal injections, number of topical glaucoma therapy drugs and intraocular pressure (IOP) were recorded. Spectral Domain Optical Coherence Tomography (SD-OCT) – Heidelberg® – was done at each visit. Outcome measures included mean changes in BCVA, central foveal thickness (CFT), IOP and additional procedures or intravitreal injections after the implant. A minimum follow-up of 6 months after the implant was defined.

Results:

The mean age of patients was 68,7±8,1 years in group 1 and 66,7±9,3 in group 2 (P>0,05). The mean duration of diabetic macular edema was 37,8±16,8 months in group 1 and 37,2±12,1 months in group 2 (P>0,05). Previously to implants the mean number of intravitreal injections of anti-angiogenics was 3,2±2,4 (79% of eyes) in group 1 and 4,9±4,3 (88% of eyes) in group 2 (P>0,05). 96% of eyes had history of intravitreal triamcinolone injections (mean 2,6±1,4) in group 1 and 63% (mean 1,4±0,5) in group 2 (P<0,05). There were no differences between groups in the time from pars plana vitrectomy until implant injections (P>0,05). In group 1 the mean change from baseline central retinal thickness (550±188μm) was -186 μm (-6, -673 μm) at the first month (P<0.001 – n=24), -205 μm (+148, -678 μm) at the third month (P<0,001 – n=20); -220 μm (+75, -675 μm) at the sixth month (p<0,001 – n=17), -275 (+98, -675 μm) at the ninth month (p=0,005 – n=10), and -240 (+274, – 663 Î ¼m) at one year of follow-up (P>0,05 – n=8). The mean increase in BCVA from baseline (40,5±19,9 letters) was 8,3 letters (-10, +43 letters) at the first month (P=0.003 – n=24), 11,6 letters (-10, +43) at the third month (P=0,003 – n=20), 14,8 letters (-12, +53) at the sixth month (P=0,0003 – n=17), 21,2 (+5, +40) at the ninth month (P=0,014 – n=10) and 18,8 letters (+5, +31) at one year of follow-up (P>0,05 – n=8). None eyes received intravitreal injections during follow-up. 20,8% (n=5) had a significant increase in intraocular pressure requiring additional therapeutic. In group 2 the mean change from baseline central retinal thickness (492±161 μm) was -136 μm (+67, -317 μm) at the first month (P=0.001), -122 μm (-8, -314 μm) at the second month (P<0,001) and -96 μm (+165, -309 μm) at the third month (p=0,03). The mean increase in BCVA from baseline (43,1±22,0 letters) was 5,7 letters (0, +20 letters) at the first month (P=0.02) and 5,1 letters (-8,+33) at the second mo nth (P>0.05) and 0,9 letters (-13, +31) at the third month (P>0.05). 50% of the cases received intravitreal injections during follow-up, mean time until procedure 4,8 months, in 31,2% (n=5) was implanted an FAc implant, 2 eyes had performed intravitreal injection of antiangiogenics and one eye was injected with triamcinolone. 31,2% (n=5) had a significant increase in intraocular pressure requiring additional therapeutic, and two of these were submitted to cyclodestructive glaucoma procedures.

Conclusion:

Treatment with fluocinolone acetonide and dexamethasone intravitreal implants led to statistically and clinically significant improvements in both vision and diabetic macular edema in difficult-to-treat vitrectomized eyes. Fluocinolone acetonide demonstrate longer and more significant results in visual acuity and macular thickness and seems to have a more acceptable safety profile particularly in intraocular pressure.


CONTACT DETAILS

 

Bernardete Pessoa
Porto, Portugal
Email : bbtpessoa@gmail.com
Cell Phone: +351938469884
Work Phone: +351938469884