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Michael D. Bennett, Karl E. Waite; High Frequency Pegaptanib for Rapid Restoration of Vascular Endothelial Growth Factor (VEGF) Levels in Diabetic Retinal Edema: The GUARDIAN Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):396.
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To evaluate the efficacy and safety of initial high frequency loading of intravitreal pegaptanib, followed by gradual dosing extension to monthly injections in subjects with diabetic macular edema (DME).
Enrolled in this prospective, 24-week, open-label study were subjects with diabetic macular edema and corresponding leakage, foveal thickness ≥250 microns, and BCVA 20/40 to 40/400 (Snellen), in whom focal laser could be deferred for ≤18 weeks. If both eyes were eligible, one eye was randomized as the study eye; the fellow eye was given standard care but underwent all study assessments. In the study eye, intravitreal pegaptanib sodium 0.3 mg was administered every 2 weeks for 3 doses, every 3 weeks for 2 doses, and then every 4 weeks for 3 doses. Efficacy outcome measures include changes in BCVA and central foveal thickness on spectral domain optical coherence tomography. Eyes with central foveal thickness >75 microns from baseline and loosing 3 lines from the best previous BCVA letter score were considered treatment failures. Adverse events including changes in intraocular pressure, and the occurrence of cataract, retinal detachment, and endophthalmitis were monitored.
To date, 4 patients have been enrolled with a median Day 0 BCVA and center point thickness of approximately 20/60 and 362μm respectively. At week 12 the median BCVA and center point thickness improved to approximately 20/40 and 259μm respectively. 24 week data will be presented.
Interim results of this small pilot study suggest that increasing dosing frequency of anti-VEGF drug administration to address high levels of VEGF at initial presentation may provide positive outcomes. Randomized clinical trials are needed to confirm these findings.
Clinical Trial: :
http://www.clinicaltrials.gov RIH 1006
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