Abstract
Abstract: :
Purpose: To assess the safety and efficacy of VRT-1001 as a method to reduce vitreoretinal traction in subjects with primary rhegmatogenous retinal detachment (PRRD) susceptible to treatment by pneumatic retinopexy. Methods: Prospective, longitudinal, descriptive and experimental study. Consecutive patients of both genders with PRRD eligible for treatment with pneumatic retinopexy were enrolled after informed consent. A 0.3ml intravitreal dose of VRT1001 was injected and pneumatic retinopexy was performed the next day, using 0.4ml of 100% C3F8. Argon laser was applied as soon as possible to seal the retinal tears. Patients were monitored with biomicroscopy, fundus photography and retinal fluorescein angiography (FAG), ultrasonography (USG) and electroretinography (ERG). Best corrected visual acuity (BCVA), intraocular pressure (IOP), location of retinal lesions, vitreous status, retinal reapplication, complications and adverse effects were all recorded. Complete and stable retinal reapplication was considered as a success after three-month follow-up. Results: Twelve eyes of 12 patients with PRRD were assessed. One did not complete follow-up. Age ranged between 27 and 60 years (mean 45.8±9.7). A stable and complete retinal reapplication was achieved in all eyes during the follow-up. Final BCVA was 20/40 or better in 50% of the eves (p=0.01). 9.1% maintained their initial BCVA, 9.1% improved 1 line and 81.8% improved 2 lines. Average improvement in the number of letters of the ETDRS charts was 19.5 at 1 month and 21 at 3 months. No change in IOP was observed. The ERG was sub-normal, as expected after PRRD, with no evidence of retinal toxicity, showing an improvement at the end of the study. No alterations were observed in the FAG. Minor complications occurred and they were resolved within a few days. No adverse effects were reported. Conclusion: Early data in this small series, suggests safety and efficacy in using this drug as an adjuvant in pneumatic retinopexy to improve the success rate in retinal reapplication. Further evaluation is encouraged.
Keywords: 563 retinal detachment • 628 vitreoretinal surgery • 436 injection