NCT00787319

Brief Summary

To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

11 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

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 13, 2013

Completed
Last Updated

December 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

November 6, 2008

Results QC Date

May 15, 2013

Last Update Submit

November 6, 2018

Conditions

Age-related Macular Degeneration

Keywords

OphthalmologyAge-related macular degenerationoutpatients

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Visual Acuity (VA) at Final Visit

    Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

    Baseline, Final Visit (Week 104 or early termination [ET])

Secondary Outcomes (3)

  • Change From Baseline in Visual Acuity (VA) at Each Visit

    Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

  • Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination

    Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

  • Physician's Assessment of Efficacy

    Week 104 or End of study (EOS)

Other Outcomes (5)

  • Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring

    Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

  • Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)

    Baseline up to Week 104 (EOS)

  • Duration of Treatment

    Baseline up to Week 104 (EOS)

  • +2 more other outcomes

Study Arms (1)

AMD

Other: no intervention

Interventions

no interventionOTHER

Outpatients with age-related macular degeneration (AMD)

Also known as: observation only
AMD

Eligibility Criteria

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

outpatients

You may qualify if:

  • age over 18 years old
  • patients with neovascular age-related macular degeneration
  • enrollment to study is fully on physician decision in compliance with current SPC

You may not qualify if:

  • Patient who did not meet indication according to SPC Macugen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Brno, 625 00, Czechia

Location

Pfizer Investigational Site

Brno, 62500, Czechia

Location

Pfizer Investigational Site

Olomouc, 775 20, Czechia

Location

Pfizer Investigational Site

Olomouc, 77520, Czechia

Location

Pfizer Investigational Site

Ostrava - Poruba, 70852, Czechia

Location

Pfizer Investigational Site

Pilsen, 304 60, Czechia

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Prague, 12808, Czechia

Location

Pfizer Investigational Site

Prague, 169 00, Czechia

Location

Pfizer Investigational Site

Prague, 169 02, Czechia

Location

Pfizer Investigational Site

Ústí nad Labem, 40113, Czechia

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

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 CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 6, 2018

Results First Posted

August 13, 2013

Record last verified: 2018-11

Locations

CZ(11)