Session Title: Quick Fire Free Paper Session 04
Session Date/Time: Sunday 29/09/2013 | 11:00-13:00
Paper Time: 12:45
Venue: Hall C (Level 1)
First Author: J.Figueira PORTUGAL
Co Author(s): S. Leal M. Cachulo N. Sandrina A. Pedroso
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).
AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal; CRIO / CHUC – Centro de Responsabilidade Integrado de Oftalmologia, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
Twenty-two (22) 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 in monotherapy in the treatment of patients with HR-PDR without any previous laser treatment. Patients were randomized in a 1:1 ratio to one of the treatment arms: 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.
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+progressive 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 however 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). Results of 1 year follow-up will be also presented at the congress.
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."