Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration (MACULA)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01245387
First received: September 29, 2010
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.


Condition Intervention
Macular Degeneration
Age-related Macular Degeneration
Neovascular Macular Degeneration
Drug: Pegaptanib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Non-Interventional Study (AB Study) To Investigate The Efficacy And Safety Of Macugen® In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Visual Acuity (VA) [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ] [ Designated as safety issue: No ]
    VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).

  • Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score [ Time Frame: Baseline, every 6 months up to Month 24 or early termination ] [ Designated as safety issue: No ]
    Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.

  • Number of Participants With Investigator Assessments of Efficacy [ Time Frame: Month 24 or early termination ] [ Designated as safety issue: No ]
    Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.

  • Lesion Size (Number of Optic Disc Areas) [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ] [ Designated as safety issue: No ]
    Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 [ Time Frame: Week 42 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 [ Time Frame: Week 66 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

  • Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit [ Time Frame: Month 24 or early termination ] [ Designated as safety issue: No ]
    Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.

  • Number of Participants With Pigment Epithelial Detachment (PED) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 42 [ Time Frame: Week 42 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

  • Number of Participants With PED at Last Visit [ Time Frame: Month 24 or early termination ] [ Designated as safety issue: No ]
    PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.

  • Central Retinal Thickness [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ] [ Designated as safety issue: No ]
    Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

  • Number of Participants With Angiographic Subtype Reported at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 42 [ Time Frame: Week 42 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

  • Number of Participants With Angiographic Subtype Reported at Last Visit [ Time Frame: Month 24 or early termination ] [ Designated as safety issue: No ]
    Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.


Enrollment: 1001
Study Start Date: August 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Macugen Drug: Pegaptanib
Dosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.

Detailed Description:

Ophthalmologists who are experienced in doing intravitreal injections in Germany

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with neovascular age-related macular degeneration

Criteria

Inclusion Criteria:

  • patients with neovascular age-related macular degeneration

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245387

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01245387     History of Changes
Other Study ID Numbers: A5751021
Study First Received: September 29, 2010
Results First Received: December 21, 2010
Last Updated: January 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
prospective
observational
Phase 4
non-interventional
open-label

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014