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

Study Overview
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Brief Summary
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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).

Official Title
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Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: pegaptanib sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After completion of the preceding study (A5751010) Exclusion Criteria: Serious heart, kidney and/or liver disease Diabetic retinopathy

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYE001<br> | Drug: pegaptanib sodium<br>* 1 drop per dosed eye per protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 54 (initiation of A5751015 study) up to Week 198 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | 
| Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. | 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. | 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. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration