Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: pegaptanib sodium

• Registration Number: NCT00858208
• Lead Sponsor: Pfizer

Brief Summary

Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.

Detailed Description

Eligible patients in routine clinical practice

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-09
• Results First Submitted: 2012-03-14
• Results First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Results First Posted: 2012-04-11
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

adults with neovascular age-related macula degeneration

Exclusion Criteria

according to SmPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with neovascular Age-Related Macula Degeneration	pegaptanib sodium	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline Visual Acuity (VA) at the Final Visit	Baseline, Week 102 or Early Termination (ET)	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline VA at Each Visit	Baseline, every 6 weeks up to Week 102	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)	Baseline, Week 102 or ET	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit	Baseline, Month 6, 12, 18, and 24	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit	Baseline, Week 102 or ET	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit	Baseline, Week 102 or ET	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇷 Xanthi, Greece