Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion

Purpose: To evaluate the efficacy and the safety of the enzymatic vitreolysis with a single intravitreal injection of ocriplasmin 125 μg across a group of patients with symptomatic vitreomacular adhesion (sVMA) during 6 months follow up. Design: A randomized, placebo-controlled, double-masked, 6-month follow up study. Participants: A total of 28 patients (12 M / 16F) (19 receiving ocriplasmin; 9 receiving placebo), mean aged 71 years old, diagnosed with sVMA, VMT, FTMH e ERM by optical coherence tomography. Methods: A single intravitreal injection of ocriplasmin 125 μg or placebo. Primary endpoint was sVMA resolution or FTMH closure. Secondary endpoint included the integrity of the external membrane and the inner and outer segments of the photoreceptor interface using OCT. The evaluation was carried out at baseline and during 6 months after intravitreal injection of ocriplasmin or placebo. Results: After a 6 months follow-up period, the rate of VMA resolution was 42.1% in the Ocriplasmin group vs the 22% in the placebo group. FTMH closure rate was 50% in the Ocriplasmin group vs 0% in the placebo group. The best results were optained within 28 days from the treatment. No case of uveitis, endophthalmitis, retinal tears, retinal detachment or bleeding during followup were reported. One patient reported floaters and transitional photopsias. Conclusions: The study confirmed the efficacy and safety of Ocriplasmin injection for patients with VMT, including when associated with full-thickness macular holes during six months follow up. Long term studies are certainly needed to confirm these results.