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

March 14, 2012 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible patients in routine clinical practice

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline Visual Acuity (VA) at the Final Visit
Time Frame: 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.
Baseline, Week 102 or Early Termination (ET)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline VA at Each Visit
Time Frame: 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.
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)
Time Frame: 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.
Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Time Frame: 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.
Baseline, Month 6, 12, 18, and 24
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Time Frame: 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.
Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Time Frame: 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.
Baseline, Week 102 or ET

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline VA at Final Visit by Age Group
Time Frame: Baseline, Week 102 or ET
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
Time Frame: Baseline, Week 102 or ET
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
Time Frame: Baseline, Week 102 or ET
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
Time Frame: Every 6 weeks up to Week 102
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
Time Frame: Every 6 weeks up to Week 102
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
Time Frame: Every 6 weeks up to Week 102
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
Time Frame: Baseline through Week 102
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)
Time Frame: Baseline and Week 102 or ET
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5751028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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