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Pegaptanib Sodium for Small Neovascular AMD Lesions
NCT00324116Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2006
- Primary completion
- Aug 2008
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Antisense DNA, RNA Aptamers, Small Interfering RNA (siRNA)
- Drugs
- pegaptanib sodium
- Conditions
- exudative age-related macular degeneration
01
Overview
Phase 4, open-label, single-arm trial of pegaptanib sodium in exudative age-related macular degeneration, sponsored by Pfizer. Primary endpoint: Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) at 54 weeks. Started Jul 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Active
Pegaptanib sodium 0.3 mg/eye intravitreous injection every 6 weeks for 54 weeks
03
Who it enrols
Patients with juxtafoveal or subfoveal CNV secondary to AMD with lesion size < 2 MPS disc areas and BCVA > 54 letters. Excludes patients with prior AMD therapy, other causes of CNV, or recent intraocular surgery.
04
Endpoints
Primary
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Secondary
Change From Baseline in Visual Acuity
Number of Subjects Gaining Vision
Number of Subjects Maintaining Vision
Number of Subjects With Severe Visual Loss
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25)
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