To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Time frame: Baseline, 54 Weeks
Change From Baseline in Visual Acuity
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.
Time frame: Baseline, 6 weeks, 12 weeks, 54 weeks
Number of Subjects Gaining Vision
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time frame: 54 weeks or at early termination
Number of Subjects Maintaining Vision
Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Angers, Cedex 09, France
Pfizer Investigational Site
Lyon, Cedex 4, France
Pfizer Investigational Site
Besançon, Cedex, France
Pfizer Investigational Site
Créteil, Cedex, France
Pfizer Investigational Site
Mâcon, Cedex, France
Pfizer Investigational Site
Poitiers, Cedex, France
Pfizer Investigational Site
Bayonne, France
Pfizer Investigational Site
Belfort, France
Pfizer Investigational Site
Bordeaux, France
Pfizer Investigational Site
Bordeaux, France
...and 24 more locations
Time frame: 54 weeks or at early termination
Number of Subjects With Severe Visual Loss
Subjects with severe visual loss: loss from baseline of \>= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time frame: 54 weeks or at early termination
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Subjects with improving scores are those with \> 20/200 at Baseline and progressing to =\< 20/200 at Week 54. Subjects with no change are those with \> 20/200 at Baseline and remaining at \> 20/200 at Week 54.
Time frame: 54 weeks
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Time frame: Baseline, 54 weeks or at early termination