Purchase this article with an account.
Roberto Diaz-Rohena, Alex Kartvelishvili, Victor H. Gonzalez; Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease (PRESerVe) Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):349.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To analyze the effect that the administration of intravitreal pegaptanib sodium injections every 4 weeks, as compared to every 6 weeks, have on best-corrected visual acuity (BCVA) and on area and volume of diabetic macular edema (DME) as measured by optical coherence tomography (OCT) in patients with DME.
A total of 72 patients in 10 study sites across the United States were enrolled. A total of 64 patients completed the study. Only 1 eye from each patient was included in the study. All study eyes had foveal thickness of 250 microns or more on OCT, and BCVA between 70 and 20 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Eyes that had any confounding factors, that could cause macular edema or decrease in vision or could interfere with treatment results, were excluded. The study was conducted in compliance with the Declaration of Helsinki, and all patients signed informed consent.
There was a total of 49 patients in the 4-week arm, and 23 patients in the 6-week arm. Mean baseline visual acuity (VA), central subfield thickness (CST), macular volume, and center point thickness (CPT) were comparable between the 2 study arms. Mean change in visual acuity by week 24 was +7.2 letters in 4-week arm, and +0.2 letters in 6-week arm (P= 0.018). Mean change in CST on OCT at week 24 was -9 microns in 6-week arm, and -71 microns in 4-week arm (P= 0.042). Mean change in macular volume on OCT at week 24 was -0.9 mm3 in 6-week arm, and -0.42 mm3 in 4-week arm (P= 0.446). Mean change in CPT on OCT at week 24 was -2 microns in 6-week arm, and -47 microns in 4-week arm (P= 0.240).
The results demonstrate that the administration of pegaptanib sodium injections every 4 weeks as opposed to every 6 weeks resulted in higher gain of letters on ETDRS chart. CST also improved more in 4-week arm than in 6-week arm, although macular volume and CPT failed to show statistically significant difference between the 2 groups.
Clinical Trial: :
This PDF is available to Subscribers Only