Abstract
Purpose :
To evaluate the safety and preliminary efficacy of 125µg of a single intravitreal injection of ocriplasmin in patients with diabetic macular edema (DME) and focal or loose broad vitreomacular adhesion/traction (VMA/VMT).
Methods :
Interventional, single center observational case series of 11 eyes of 9 patients who received intravitreal ocriplasmin for DME with VMA/VMT. Adjunct treatment, when required, with laser and intravitreal injections of corticosteroids and/or antiangiogenic before or after the injection of ocriplasmin were also performed. The primary endpoint was resolution of vitreomacular adhesion at 1 month post intervention. The secondary endpoints included VMA release or decrease size of VMA over time, total posterior vitreous detachment (PVD), macular edema, best corrected visual acuity (BCVA) changes from baseline and number of anti-vascular endothelial growth factor (VEGF) injections.
Results :
11 eyes of 9 patients were treated with an intravitreal injection of ocriplasmin. The mean follow-up was 128 days (range between 81 and 223). Of the 9 patients, with an average age of 69 years, 64% are male and 55% of the cases are phakic. The mean BCVA pre-injection was 20/50 (ETDRS Scale). Non-proliferative diabetic retinopathy was present in 82% of the eyes. There was history of intravitreal injections (anti-angiogenic and/or steroids) in 82% of cases and 100% laser therapy. The average time of vitreo-macular traction was 11 months. The average measure of traction was 878μm (minimum 128μm and maximum values of 2765μm) and an epiretinal membrane was found on OCT in 9% of the cases. Floaters and/or photopsias were described in 45% of patients in the first days after the injection. The release of the TVM occurred in 64% of cases and PVD in 45.5%. There was an increase of BCVA in 82% of cases (p<0.05). The mean macular thickness decreased from 311.2μm pre-injection to 291.1μm (p=0.041).
Conclusions :
The intravitreal injection of ocriplasmin in DME associated with VMT seems to be a safe and well tolerated procedure and an effective treatment with a significant improvement in visual acuity and macular edema. The anatomical-functional preliminary results suggest that this approach could be a therapeutic alternative in the DME with VMT, being the patient’s selection and the timing of injection crucial for a successful treatment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.