Phase 2
N=61
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00239928 ↗Enrolled (actual)
61
Serious AEs
26.2%
Results posted
May 2011
Primary outcome: Primary: Summary of Adverse Events — 57; 16; 47; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pegaptanib sodium (Drug)
- Age
- Adult, Older Adult · 51+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Adverse Events |
57; 16; 47; 4; 1; 1 | — |
| SECONDARY Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point |
-3.2; -3.3; -4.7; -8.6; -8.6; -10.1 | — |
| SECONDARY Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point |
-0.1; -1.4; -4.8; -4.5; -6.1; -6.3 | — |
| SECONDARY Number of Responders |
41; 41; 37; 33; 32; 30 | — |
| SECONDARY Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) |
4; 7; 7; 6; 6; 5 | — |
| SECONDARY Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) |
24; 20; 21; 16; 17; 15 | — |
| SECONDARY Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) |
0; 1; 4; 7; 6; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT00239928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.