Comparison of safety profile between our study and other dexamethasone implant studies
| Study | No of eyes (no of injections) | Follow-up | Indications | Rise in IOP | Cataract | Systemic adverse events | Other side effects |
| Our study | 2736 (6015) | 18.9±16.1 months (range: 6 to 102 months) | DME RVO Uveitis Irvine-GassMiscellaneous | 20% glaucoma (2% - no Rx, 91% -AGM, 3.14% -surgery, 0.35% -SLT) | 47.1% 32.5% -surgery | Death due to chronic renal failure, herpes zoster (both unrelated to Ozurdex) | Endophthalmitis - 2 RD - 1 |
| Boyer et al opthalmology 201419 | 1048 | 3 years | DME | 700 mcg - Iop rise - 125 (36%) 144 (41.5% - AGM 2% – 0.6% - trab) 350 mcg Iop rise 117 (34.1%) 129 (37.6% - AGM),1 (0.3% - trab) Sham 18 (5.1%) | 67.9% (59.2% -surgery 64.1% (52.3% -surgery) 20.4% (7.2% -surgery) | Nil | Vitreous haemorrhage -1 |
| Schmitz et al ZERO study 201420 | 342 | 8 months | RVO | 20% | 0.2% -surgery | Not reported | Macular hole - 2 Implant dislocation anteriorly - 2 Vitreous haemorrhage - 6 |
| Filho et al
ophthalmologica 201925 | 329 | Not specified | DME | 7.4% | 4% | Not reported | Endophthalmitis - nil |
| GENEVA ophthalmology 201126 | 1256 (two injections) | 12 months | BRVO CRVO | 12.6% Controlled with AGM | 29.8% 700 mcg 5.7% sham (1.3% -surgery) | Not reported | Retinal detachment -1 |
| Li et al
Graefes 201827 | 259 eyes | 6 months | RVO | 27.1% increase in IOP >10 mm Hg 23.3% >25 mm Hg 6.2% >35 mm Hg (34.9% - AGM 1 - LT) | 1.6% IVD vs 0 sham | AV block Cerebral infarction (unrelated to Dex implant) | Conjunctival haemorrhage 24 (18.6) Conjunctival hyperaemia 17 (13.2) Conjunctival oedema 4 (3.1) Eye pain 3 (2.3) Headache 3 (2.3) |
| Eter N Graefes 201728 | 573 eyes (668 implants) | 6 months | RVO | 13.2% IOP >25 mm Hg (39% of these needed AGM 1.6% - LT) | 6.1% -surgery | Not reported | Nil |
| Malclès et al Retina 2017 SAFODEX23 | 421 eyes (1000 injections) | 16.8 months (3 to 55 years) | RVO DME Post surgical others | 28.5% 31% - AGM 07% - surgery | Not reported | Not reported | Nil |
| Nagpal et al
TaiwanJ 201829 | 116 | 24 months | DME RVO Infectious uveitis | 12 cases (10.3%) | nine eyes | Not reported | Nil |
| Zarranz-Ventura et al
201430 | 82 eyes | 12 months | Uveitis | 40.2% (2.4%) | 4 (4.8%) | Not reported | Vitreous haemorrhage -1 eye |
| Mayer et al
eye 201331 | 64 eyes | 12 months | BRVO CRVO | 40% rise in IOP (1 CPC, others –AGM) | Not reported | Not reported | RD - 1 |
| Lowder et al
201133 | 229 | 26 weeks | Uveitis | 7.1% (700 mcg) 8.7% (350 mcg) | 700 mcg 15% (1.6% -surgery) 350 mcg 12% (0 -surgery) | Not reported | Endophthalmitis (sterile) − 1 eye RD - 2 eyes |
| Zarranz-Ventura et al 201932 | 429 eyes (705 injections) | 24 months | DME RVO Uveitis Off-label | 28.7%* IOP change >10 mm Hg 30%*- >25 mm Hg 7%*>35 mm Hg 54%* - AGM 0.9% - glaucoma surgery (*cumulative probabilities at 24 months) | Not reported | Not reported | None |
| Reid GA Retina 201534 | 61 eyes | 6 months | RVO | 10 (12%) 11% - AGM 1.2% - surgery | First implant - 13.2% Second implant - 45% Third implant - 60% 24.1% - cataract surgery | Not reported | None |
| Maturi et al MEAD study 201636 | 1040 eyes | 3 years | Diabetic macular oedema | 700 mcg - 36.0% 350 mcg - 34.1% Sham - 5.1% AGM (41.5%/37.6%/9.1%) | 24% -surgery | Not reported | None |
| Ozkaya Int Jo 201737 | 87 eyes 104 injections | 2 years | BRVO IVD vs RBZ | 27.3% vs 0 | 46.1%(IVD) vs 5.7%(RBZ) IVD-5(0.12%) - surgery | Not reported | None |
AGM, anti-glaucoma medication; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; DME, diabetic macular edema; IOP, intraocular pressure; IVD, intravitreal dexamethasone; RBZ, ranibizumab; RD, retinal detachment; RVO, retinal vein occlusion; SLT, selective laser trabeculoplasty.