Combination of intravitreal injection of Pegaptanib plus progressive PRP versus full PRP alone in patients with High Risk Proliferative Diabetic Retinopathy

Abstract

Purpose: To evaluate safety and efficacy of intravitreal (ITV) injection of pegaptanib combined with progressive panretinal photocoagulation (PRP) versus full PRP alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy (HR-PDR).

Methods: Twenty-two patients were included in a prospective, randomized, open label exploratory, phase II study to assess safety and efficacy of pegaptanib (0.3 mg ITV injections)+progressive PRP and full PRP alone in the treatment of patients with HR-PDR without previous laser treatment. Patients were randomized in a 1:1 ratio to one treatment arm: standard photocoagulation (PRP according the Diabetic Retinopathy Study; DRS), or combination treatment of pegaptanib ITV injections+progressive PRP (2 weeks±1 week after the first injection, starting with DRS third ring, extending from the ora serrata to the mid-periphery with coalescing spots followed, if needed, by the DRS second and first ring). One eye was selected and treated as the study eye. Patients underwent at baseline, months 3, 6 and 12: Best Corrected Visual Acuity (BCVA), Color Fundus Photography (CFP), Fluorescein Angiography (FA), Spectral Domain Optical Coherence Tomography (SD-OCT) and Visual Fields (VF). Retinal neovascularization (NV) was measured in disc area units based on CFP and/or FA.

Results: 20 patients completed the first 6 months of follow-up (16 males and 4 females). Age ranged from 38 to 76 (mean±SD: 54.8±9.9 years). Mean HbA1C was 7.9±1.5% and the systolic and diastolic blood pressure was respectively of 142.4±11.1 and 79.7±6.3 mmHg. From baseline to month-6, in the pegaptanib+ PRP group the BCVA decreased less (PRP: 77.8±8.4 to 71.6±15.7, P=0.075; pegaptanib+PRP: 69.0±15.6 to 68.1±20.9, P=0.651); RT showed a lower increase (PRP: 321.1±151.4 to 394.0±183.9, P=0.012; pegaptanib+PRP: 411.1±190.7 to 479.3±252.4, P=0.327); and VF was better maintained (PRP: 37.8±18.4 to 31.7±19.7, P=0.044; pegaptanib+PRP: 28.6±16.8 to 27.1±18.5, P=0.202). NV regression was similar in both groups (PRP: 3.1±4.9 to 2.6±3.5, P=0.678; pegaptanib+PRP: 3.2±2.7 to 2.5±2.7, P=0.213).

Conclusions: The association of ITV pegaptanib with progressive PRP showed at 6-months better preservation of BCVA, lower increase in RT and better maintained VF than full PRP alone, but without major differences in NV regression.

Keywords: 688 retina • 499 diabetic retinopathy • 550 imaging/image analysis: clinical