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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239928
• Other study ID #: A5751015
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2005
• Last updated: May 11, 2011
• Start date: September 2005
• Est. completion date: November 2008

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

Inclusion Criteria:

• After completion of the preceding study (A5751010)

Exclusion Criteria:

• Serious heart, kidney and/or liver disease

• Diabetic retinopathy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• pegaptanib sodium
1 drop per dosed eye per protocol.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Fukushima
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Maebashi	Gunma
Japan	Pfizer Investigational Site	Moriguchi	Osaka
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Otsu	Shiga
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo
Japan	Pfizer Investigational Site	Suita	Osaka
Japan	Pfizer Investigational Site	Urayasu	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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