A retrospective, pooled data analysis of the safety of pegaptanib sodium in the treatment of age-related macular degeneration in subjects with or without diabetes mellitus

Table 1 Clinical studies included in the analysis in which subjects received 0.3 mg pegaptanib

Study	Duration of Treatment	Treatment Groups	Pegaptanib sodium 0.3 mg		Sham	Reference
			Subjects
			With Diabetes	Without Diabetes	With Diabetes
			N = 165	N = 1421	N = 26
NCT00321997 (EOP1003; randomized)	Up to 5 years	Pegaptanib 0.3, 1, 3 mg; sham	22 (13.3%)	208 (14.6%)	7 (26.9%)	[15]
NCT00021736 (EOP1004; randomized)	Up to 5 years	Pegaptanib 0.3, 1, 3 mg; sham	20 (12.1%)	182 (12.8%)	14 (53.8%)	[17]
NCT00215670 (EOP1006; randomized)	Up to 2 years	Pegaptanib 0.3, 1, 3 mg	1 (0.6%)	41 (2.9%)	0 (0%)	[29]
NCT00087763 (EOP1009; randomized)	1 year; with no treatment weeks 12 to 24	Pegaptanib 0.3, 1 mg; sham	4 (2.4%)	60 (4.2%)	5 (19.2%)	*
NCT00088192 (EOP1010; open-label)	Up to 3 years	Pegaptanib 0.3 mg	67 (40.6%)	370 (26.0%)	0 (0%)	[30]
NCT00134667** EOP1012; randomized)	Up to 2 years	Pegaptanib 0.3 mg; pegaptanib 0.3 mg + PDT	16 (9.7%)	149 (10.5%)	0 (0%)
NCT00150202/ NCT00239928 (A5751010/ A5751015; open-label)	Up to 4 years	Pegaptanib 0.3, 1 mg	7 (4.2%)	72 (5.1%)	0 (0%)	[30]***
NCT00324116 (A5751016; open-label)	1 year	Pegaptanib 0.3 mg	11 (6.7%)	70 (4.9%)	0 (0%)	†
NCT00327470 (A5751017; open-label)	Up to 2 years	Pegaptanib 0.3 mg	17 (10.3%)	269 (18.9%)	0 (0%)	†

PDT: photodynamic therapy with verteporfin.
*Unpublished observation ([by author or pharma, year]).
**Unpublished results; trial terminated.
***Study A5751015 was an extension of study A5751010 and were considered as a single study for this manuscript.
^†Unpublished observations (Estephan M, Troy S, Starita C, for the French Macugen in Early Onset CNV Study Group presented at European Society of Retina Specialists - 10th EURETINA Congress. Paris, France; 2010: Poster 1016).

ISSN: 1471-2415