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
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 April 15, 2014