This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
1 drop per dosed eye per protocol.
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Summary of Adverse Events
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
Time frame: Week 54 (initiation of A5751015 study) up to Week 198
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Time frame: Weeks 54, every 18 weeks from Week 54 up to Week 198
Number of Responders
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
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Pfizer Investigational Site
Fukushima, Fukushima, Japan
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kyoto, Kyoto, Japan
Pfizer Investigational Site
Moriguchi, Osaka, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Ōtsu, Shiga, Japan
...and 2 more locations
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198