Introduction:
In the working age population, Diabetic Macular Edema (DME) is the most common cause of
visual loss.
Purpose:
The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus
intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre over 4 months.
Methods:
This is a comparative, prospective, randomized study that was done on 140 patients with macular edema
confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR
group received Lucentis® (Novartis, Basel, Switzerland) followed up at day-1 and weeks 4, 8, 12,16. Patients were divided
into Group A: patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B: patients given a single
dose of IVD implant 0.7 mg (n=70).
Results:
The mean number of injections given was 1 Ozurdex® per patient Vs 3 Lucentis® per patient. The maximum
reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively
with IVR. The Mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD
and IVR group, respectively with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15
letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4 %, and 20.4, 18.8, 20.3 20.3 % in IVR groups, respectively. The
maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17 %). The patients with IOP
rise >10 mmHg was observed in 14/63 patients (22.22 %), the majority of patients indicated a high rise at 2nd month and all
returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either treated
groups.
Conclusion:
Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in
lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence in
CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior
efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow-up
would be performed to justify the obtained results in the present study.