This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
131
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Marietta Eye Clinic
Murrieta, California, United States
Wolfe Eye Clinic
Marshalltown, Iowa, United States
Associates in Ophthalmology
West Mifflin, Pennsylvania, United States
Valley Retina Institute
Harlingen, Texas, United States
Change From Baseline in Mean Endothelial Cell Density
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Time frame: Baseline, Week 54
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