Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: pegaptanib sodium

• Registration Number: NCT00239928
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-04
• Results First Submitted QC: 2011-04-05
• Status Verified: 2011-05
• Results First Posted: 2011-05-04
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• After completion of the preceding study (A5751010)

Exclusion Criteria

• Serious heart, kidney and/or liver disease
• Diabetic retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EYE001	pegaptanib sodium	-

Primary Outcome Measures

Name	Time	Method
Summary of Adverse Events	Week 54 (initiation of A5751015 study) up to Week 198	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

Secondary Outcome Measures

Name	Time	Method
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point	Week 0 (baseline), every 18 weeks from Week 54 up to Week 198	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.
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point	Weeks 54, every 18 weeks from Week 54 up to Week 198	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.
Number of Responders	Week 0 (baseline), every 18 weeks from Week 54 up to Week 198	Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)	Week 0 (baseline), every 18 weeks from Week 54 up to Week 198	Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)	Week 0 (baseline), every 18 weeks from Week 54 up to Week 198	Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)	Week 0 (baseline), every 18 weeks from Week 54 up to Week 198	Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Kyoto, Japan