First Author: C.A.Putri UK
Co Author(s): A. Jain A. Hoi Ki Lo M. Wasim 0 0 0 0 0 0 0 0 0
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Macular oedema is a leading cause of blindness in patients with retinal vein occlusion and diabetic retinopathy. The development of long-acting intravitreal dexamethasone implant (Ozurdex) has offered a more effective and safer treatment for macular oedema. Ozurdex is currently only licensed for the treatment of macular oedema secondary to central/branch retinal vein occlusion (CRVO/BRVO) and posterior segment uveitis. However, clinical studies show that Ozurdex is a promising new treatment for diabetic macular oedema (DMO). The aim of this study is to evaluate the effectiveness and safety of Ozurdex implant for treatment of macular oedema secondary to CRVO, BRVO and DMO.
This study was conducted at the ophthalmology department of Royal Oldham Hospital, UK. This is a district general hospital in north Manchester area.
A prospective study, collecting data from 27 Eyes of 25 patients with persistent macular oedema secondary to BRVO (22%), CRVO (22%) and diabetic retinopathy (56%) who had Ozurdex implanted from May 2012 to March 2013, was conducted. Diabetic maculopathy patients were studied as a pilot project in resistant cases where intravitreal therapy failed. Exclusion criteria included raised intraocular pressure (IOP) and intraocular surgery within 3 months. Primary outcomes included the improvement in BCVA at week 1, month 2 and month 6 post-implantation. Secondary outcomes included the improvement in central retinal thickness (CRT), duration of macular oedema, change in IOP, change in lens appearance, change in anterior chamber appearance, average HBA1c, type of anaesthesia used and complications.
For BRVO, the mean change from baseline BCVA were 15±18 (p=0.32), 18±16 (p=0.34) and 10±17 (p=0.54) at week 1, month 2 and 6 respectively. For CRVO, the mean change from baseline BCVA were 4±8 (p=0.44), 10±12 (p=0.77) and 5±9 (p=0.57) at week 1, month 2 and 6 respectively. For DMO, the mean change from baseline BCVA were 4±4 (p=0.37), 5±7 (p= 0.23) and 1±5 (p=0.65) at week 1, month 2 and 6 respectively. Mean reductions in CRT at 2 months were 254±212µm (p=0.02) for BRVO, 191±201µm (p=0.08) for CRVO and 127±177µm (p=0.09) for DMO. In 6 months, 11% of eyes observed needed treatment with IOP-lowering drops and 7% had increased lens opacity. All eyes observed did not show any significant anterior chamber activities post-implantation. Other reported complications included dry eyes (11%), lightheadness (3%), eye discomfort (3%), subconjunctival haemorrhage (3%), and aponeurosis injury (3%).
Ozurdex was clinically effective in treatment of macular oedema secondary to BRVO and CRVO as substantial improvements were registered in both visual acuity and CRT. The improvement in visual acuity and CRT were less in patients with DMO. Relatively poor results in the diabetic group may be related to these being refractory cases with very longstanding disease. Limitation of this study is in the small sample size. Safety profile of Ozurdex is acceptable with no significant complication. Based on this study and other relevant studies, Ozurdex can safely be used not only as a routine licensed treatment for macular oedema secondary to BRVO and CRVO but also as unlicensed treatment for DMO. It is also recommended to repeat the treatment with Ozurdex every 2 to 6 months if the patient responds to the treatment. Strict routine follow up in vascular or diabetic eye clinics with optical coherence tomography (OCT) is recommended at week 1, month 3 and 6 post-implantation of Ozurdex.