Clinical trial NCT00239928: Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Official title: Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 61
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* After completion of the preceding study (A5751010)

Exclusion Criteria:

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

Primary outcomes:
measure: Summary of Adverse Events
timeFrame: Week 54 (initiation of A5751015 study) up to Week 198
Secondary outcomes:
measure: Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
timeFrame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
measure: Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
timeFrame: Weeks 54, every 18 weeks from Week 54 up to Week 198
measure: Number of Responders
timeFrame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
measure: Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
timeFrame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
measure: Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
timeFrame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
measure: Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
timeFrame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Urayasu
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Maebashi
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Moriguchi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Otsu
country: Japan
facility: Pfizer Investigational Site
state: Shiga
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: