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

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.

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: pegaptanib sodium

Detailed Description

Eligible patients in routine clinical practice

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Greece
  • Alexandroupoli, Greece
    • Pfizer Investigational Site
  • Athens, Greece, 12462
    • Pfizer Investigational Site
  • Athens, Greece
    • Pfizer Investigational Site
  • Larisa, Greece
    • Pfizer Investigational Site
  • Patra, Greece
    • Pfizer Investigational Site
  • Thessaloniki, Greece
    • Pfizer Investigational Site
  • Xanthi, Greece
    • Pfizer Investigational Site
  • Pellopoese
    • Patras, Pellopoese, Greece
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Age-related Macula degeneration

Description

Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with neovascular Age-Related Macula Degeneration	Drug: pegaptanib sodium; pegaptanib sodium intravitreal injection every 6 weeks for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline VA at Final Visit by Age Group	Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR 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 logMAR scale represents improvement in VA.	Baseline, Week 102 or ET
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage	Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR 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 logMAR scale represents improvement in VA.	Baseline, Week 102 or ET
Change From Baseline VA at the Final Visit by Previous Treatment of AMD	Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR 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 logMAR scale represents improvement in VA.	Baseline, Week 102 or ET
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment	Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.	Every 6 weeks up to Week 102
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment	Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.	Every 6 weeks up to Week 102
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment	Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.	Every 6 weeks up to Week 102
Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study	Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).	Baseline through Week 102
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)	IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.	Baseline and Week 102 or ET

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: efficacy and safety of Macugen in routine clinical practice
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: A5751028