Abstract
Purpose: :
To compare our findings after intravitreal injection of Bevacizumab (Avastin) versus Ranibizumab (Lucentis) as monotherapy in treatment-requiring Retinopathy of Prematurity in a four-year follow-up.
Methods: :
Six premature infants with stage 3 threshold or prethreshold ROP were included. After signature of informed consent by the parents, patients underwent injection of either intravitreal Bevacizumab or Ranibizumab in a non-randomized fashion.Under topical anesthesia and aseptic technique, using a lid speculum, 1 mm from the limbus was measured with a caliper, and either 0.75 mg of bevacizumab or 0.3 mg of ranibizumab were injected into the vitreous cavity using a 30 gauge needle. No anterior chamber paracentesis was made. Patients were evaluated at day 1, 7, and month 1, 3, 6, 12, 18, 24,36 and 48 undergoing dilated fundus examination. If recurrent neovascularization was observed, the eye was reinjected. Ocular and systemic adverse events were recorded.
Results: :
Six patients (twelve eyes) were included. Three patients (six eyes) received off-label Bevacizumab (0.03ml), the same number of patients and eyes received off-label Ranibizumab (0.03ml). At a 2-year follow up, regression of neovascularization and normal vascular growth was found in all patients, no systemic complications were recorded and neurodevelopmental findings were normal. No ocular adverse events were recorded in any of the two groups. Best corrected visual accuity with Adler charts was on average logMar 0.2 (range 0.3-0.0).
Conclusions: :
Our results suggest no significant difference between Bevacizumab and Ranibizumab in treatment-requiring ROP. Antiangiogenic therapy is a promising therapy for patients with stage3 ROP. Further studies are needed to establish the ideal time of treatment, long term safety and efficacy issues, and whether it should be used as stand-alone therapy, or as adjuvant to laser and/or cryotherapy.
Clinical Trial: :
http://ctri.nic.in/Clinicaltrials/login.php NCT00346814
Keywords: retinopathy of prematurity • neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials