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

September 29, 2010
January 12, 2011
August 2006
December 2009   (final data collection date for primary outcome measure)
  • 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.
  • Investigator´s assessment of efficacy [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
  • visual acuity [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
  • Quality of life (NEI-VFQ25) [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • lesion size [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
  • change in activity of neovascular membrane [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01245387 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
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

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.

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with neovascular age-related macular degeneration

  • Macular Degeneration
  • Age-related Macular Degeneration
  • Neovascular Macular Degeneration
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.
Macugen
Intervention: Drug: Pegaptanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1001
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with neovascular age-related macular degeneration

Exclusion Criteria:

  • none
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01245387
A5751021
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP