NCT00858208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 11, 2012

Completed
Last Updated

April 11, 2012

Status Verified

September 1, 2011

Enrollment Period

3.1 years

First QC Date

February 26, 2009

Results QC Date

March 14, 2012

Last Update Submit

March 14, 2012

Conditions

Neovascular Age-related Macular Degeneration

Keywords

efficacy and safety of Macugen in routine clinical practice

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change From Baseline VA at Each Visit

    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)

    Baseline, Week 102 or ET

  • Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit

    Baseline, Month 6, 12, 18, and 24

  • Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit

    Baseline, Week 102 or ET

  • Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit

    Baseline, Week 102 or ET

Other Outcomes (8)

  • Change From Baseline VA at Final Visit by Age Group

    Baseline, Week 102 or ET

  • Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage

    Baseline, Week 102 or ET

  • Change From Baseline VA at the Final Visit by Previous Treatment of AMD

    Baseline, Week 102 or ET

  • +5 more other outcomes

Study Arms (1)

Patients with neovascular Age-Related Macula Degeneration

Drug: pegaptanib sodium

Interventions

pegaptanib sodiumDRUG

pegaptanib sodium intravitreal injection every 6 weeks for 2 years

Patients with neovascular Age-Related Macula Degeneration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Age-related Macula degeneration

You may qualify if:

  • adults with neovascular age-related macula degeneration

You may not qualify if:

  • according to SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Pátrai, Pellopoese, Greece

Location

Pfizer Investigational Site

Alexandroupoli, Greece

Location

Pfizer Investigational Site

Athens, 12462, Greece

Location

Pfizer Investigational Site

Athens, Greece

Location

Pfizer Investigational Site

Larissa, Greece

Location

Pfizer Investigational Site

Pátrai, Greece

Location

Pfizer Investigational Site

Thessaloniki, Greece

Location

Pfizer Investigational Site

Xánthi, Greece

Location

Related Links

MeSH Terms

Interventions

pegaptanib

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2009

First Posted

March 9, 2009

Study Start

March 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 11, 2012

Results First Posted

April 11, 2012

Record last verified: 2011-09

Locations

GR(8)