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

Neovascular Age-related Macular Degeneration Clinical Trial

— MACULA  

Official title:

Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858208
• Other study ID #: A5751028
• Status: Completed
• Phase: N/A
• First received: February 26, 2009
• Last updated: March 14, 2012
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Eligible patients in routine clinical practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• pegaptanib sodium
pegaptanib sodium intravitreal injection every 6 weeks for 2 years

Locations

Country	Name	City	State
Greece	Pfizer Investigational Site	Alexandroupoli
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Larisa
Greece	Pfizer Investigational Site	Patra
Greece	Pfizer Investigational Site	Patras	Pellopoese
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Xanthi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Visual Acuity (VA) at the Final Visit	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.	Baseline, Week 102 or Early Termination (ET)	No
Secondary	Change From Baseline VA at Each Visit	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.	Baseline, every 6 weeks up to Week 102	No
Secondary	Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)	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.	Baseline, Week 102 or ET	No
Secondary	Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit	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.	Baseline, Month 6, 12, 18, and 24	No
Secondary	Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit	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.	Baseline, Week 102 or ET	No
Secondary	Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit	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.	Baseline, Week 102 or ET	No

External Links

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