Abstract
Purpose: :
To evaluate the short-term effects of a single intravitreal injection of ranibizumab (IVR) for the management of persistent new vessels (NV) associated with diabetic retinopathy.
Methods: :
A prospective, nonrandomized, open-label study including 22 eyes of 22 diabetic patients with actively leaking retinal NV refractory to laser treatment and ETDRS best-corrected visual acuity (BCVA) worse than 20/32. Comprehensive ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (±1) following IVR (0.5 mg). Main outcome measures were total fluorescein leakage area (FLA) from active NV measured on digital fluorescein angiograms using IMAGEnet software; BCVA; and central subfield macular thickness (CSMT) measured with Stratus optical coherence tomography.
Results: :
At baseline, mean ± SEM FLA was 4.8 ± 1.2 mm2, and was reduced to 0.1 ± 0.1 mm2 (MANOVA; P=0.0009); 0.3 ± 0.1 mm2 (P=0.0011); and 2.1 ± 0.5 mm2 (P=0.0113) at 1, 6, and 12 weeks after IVR, respectively. Mean BCVA was 0.70 ± 0.08 logMAR (20/100) at baseline and improved to 0.63 ± 0.08 (20/85) (P=0.0136); 0.61 ± 0.07 (20/81) (P=0.0222); and 0.63 ± 0.08 (20/85) (P=0.0273) at 1, 6, and 12 weeks after IVR, respectively. Mean CSMT was 321.3 ± 37.8 µm at baseline and decreased significantly to 267.6 ± 22.3 µm (P=0.0373) and 276.7 ± 26.4 µm (P=0.0110) at 1 and 6 weeks after IVR, respectively; mean CSMT at week 12 (297.7 ± 31.6 µm) was not significantly different from baseline mean CSMT (P=0.1665).
Conclusions: :
A single IVR is associated with significant short-term reduction of fluorescein leakage and significant, although modest, short-term reduction of CSMT and improvement in BCVA in eyes with persistent NV due to diabetic retinopathy.
Clinical Trial: :
www.clinicaltrials.gov NCT00993525
Keywords: diabetic retinopathy • retinal neovascularization • injection