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Ocular safety of intravitreal injection of age-related macular degeneration (AMD) treatments in a prospective observational cohort study in Europe

Session Details

Session Title: AMD III

Session Date/Time: Sunday 29/09/2013 | 11:00-13:00

Paper Time: 12:12

Venue: Hall G1 (Level 2)

First Author: K.Huang USA

Co Author(s):    M. Sultan   D. Zhou   C. Tressler   J. Mo     

Abstract Details

Purpose:

AMD is the leading cause of blindness in persons 65 years of age or older in western populations. Macugen® was the first approved intravitreal vascular endothelial growth factor (VEGF) antagonist treating AMD in Europe. The primary objective of this prospective, multinational, observational study was to estimate the incidence of pertinent ocular AEs (POAEs), including endophthalmitis, retinal detachment, vitreous hemorrhage, retinal tear, traumatic cataract, and increased intraocular pressure (IOP) among neovascular AMD patients receiving IVT of Macugen in the real world setting in Europe over a two-year period.

Setting:

This study was conducted at ophthalmic clinical centers in Europe. The study was initiated in August 2006 and ended in February 2012. The study population consisted of patients who received at least one IVT of Macugen.

Methods:

Treating ophthalmologists prospectively followed study participants and determined outcomes of interest as clinically appropriate. For POAEs, new events as well as worsening of existing events were required to be reported. All POAEs events, relevant medical and ocular history, and serious adverse events (SAEs) in this study were verified against medical charts by monitors. There were no study-mandated visits. Switching to other AMD treatment was allowed under treating ophthalmologists’ discretion. After a patient enrolled in the study, the treating ophthalmologist followed the patient as per usual care. Since the per the approved summary of product characteristics IVT of Macugen is every 6 weeks, if a patient did not return to visit his/her enrolling ophthalmologist 12 weeks after receiving his/her last IVT of Macugen, the treating ophthalmologist was to contact the patient to complete a patient follow-up contact form to collect information on occurrence of POAEs. The treating ophthalmologists were allowed to include both eyes of a patient in this study if the patient received IVT of Macugen in both eyes.

Results:

501 patients from 69 sites in 13 countries were enrolled with a total of 3815 IVT for AMD treatment. The mean age was 73.6 years. Most patients received Macugen monotherapy (80.4%), were white (97.4%), and never smoked (65.3%). 11.8% of patients received IVT AMD treatment in both eyes. The mean number of Macugen injections was 6.9± 4.2 injections. The incidence of POAEs was low overall (0 to 1.3% per injection, 0 to 6.6% per patient, and 0 to 75.9 patients per 1000 patient-years at risk). Increased IOP was the most frequently reported POAE (1.3% per injection, 6.6% per patient, and 75.9 patients per 1000 patient-years at risk), with a total of 48 occurrences in 33 patients. There was a positive association between the incidence of increased IOP and the number of injections received. Endophthalmitis was not reported.

Conclusions:

The incidence of POAEs related to IVT in this study was low and similar to that in the literature. Macugen was safe and well tolerated among patients in the study.

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