González V H, Giuliari G P, Banda R M, Guel D A
Valley Retina Institute, PA, McAllen, TX 78503, USA.
Br J Ophthalmol. 2009 Nov;93(11):1474-8. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18.
To compare the efficacy of intravitreal pegaptanib (IVP) with panretinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR).
A prospective, randomised, controlled, open-label, exploratory study. Twenty subjects with active PDR were randomly assigned at a 1:1 ratio to receive treatment in one eye either with IVP (0.3 mg) every 6 weeks for 30 weeks or with PRP laser. Efficacy endpoints included regression of retinal neovascularisation (NV), changes from baseline in best-corrected visual acuity (BCVA) and foveal thickness. Safety outcomes included observed and reported adverse events.
In 90% of randomised eyes to IVP, retinal NV showed regression by week 3. By week 12, all IVP eyes were completely regressed and maintained through week 36. In the PRP-treated group, at week 36, two eyes demonstrated complete regression, two showed partial regression, and four showed persistent active PDR. The mean change in BCVA at 36 weeks was +5.8 letters in pegaptanib-treated eyes and -6.0 letters in PRP-treated eyes. Only mild to moderate transient ocular adverse events were reported with pegaptanib.
IVP produces short-term marked and rapid regression of diabetic retinal NV. Regression of NV was maintained throughout the study and at the final visit.
比较玻璃体内注射培加他尼（IVP）与全视网膜激光光凝术（PRP）治疗活动性增殖性糖尿病视网膜病变（PDR）的疗效。
一项前瞻性、随机、对照、开放标签的探索性研究。20名活动性PDR患者按1:1比例随机分配，一只眼接受每6周一次、共30周的IVP（0.3毫克）治疗，另一只眼接受PRP激光治疗。疗效终点包括视网膜新生血管（NV）消退、最佳矫正视力（BCVA）和黄斑厚度相对于基线的变化。安全性结果包括观察到的和报告的不良事件。
在接受IVP治疗的随机分组眼中，90%的患者在第3周时视网膜NV出现消退。到第12周时，所有接受IVP治疗的眼睛均完全消退，并维持到第36周。在PRP治疗组中，到第36周时，两只眼睛完全消退，两只部分消退，四只仍为活动性PDR。培加他尼治疗组在36周时BCVA的平均变化为提高5.8个字母，PRP治疗组为下降6.0个字母。培加他尼仅报告了轻度至中度短暂性眼部不良事件。
IVP可使糖尿病视网膜NV短期内显著快速消退。在整个研究期间及最后一次随访时，NV消退情况持续存在。
