Retina-Vitreous Associates, Beverly Hills, California, USA.
Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil.
Br J Ophthalmol. 2014 Nov;98(11):1543-6. doi: 10.1136/bjophthalmol-2013-304075. Epub 2014 Jul 4.
To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation.
A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory.
Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery.
In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use.
NCT00321997.
评估培加他滨相关的持续性眼内压（IOP）升高的发生率。
对 VEGF 抑制研究中眼部新生血管（V.I.S.I.O.N.）研究中所有随机接受培加他滨 0.3mg 或假注射的受试者的前 2 年中所有 IOP 测量值（除即刻注射后 30 分钟内的测量值）进行了事后分析。Goldmann 压平眼压计或 Tonopen 用于测量眼压，除非在基线时或眼压读数>30mmHg 时需要使用 Goldmann 压平眼压计。
在 221 名受试者中，培加他滨组和假注射组分别有 28/114 和 23/107 名受试者的 IOP 测量值≥22mmHg（p=0.6338），分别有 8 名和 8 名受试者的 IOP 测量值≥24mmHg。在培加他滨组和假注射组中，分别有 6 名和 10 名受试者的超过两次 IOP 测量值≥22mmHg（p=0.3025），分别有 1 名和 4 名受试者的超过两次 IOP 测量值≥24mmHg。培加他滨组中有 1 名受试者、假注射组中有 4 名受试者在研究过程中添加了降眼压药物。没有受试者需要接受青光眼手术。
在 V.I.S.I.O.N.研究中，经过 2 年，没有证据表明培加他滨 0.3mg 治疗与持续性 IOP 升高有关。
NCT00321997。
