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Trial record 1 of 1 for:    NCT01245387
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Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration (MACULA)

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ClinicalTrials.gov Identifier: NCT01245387
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : January 7, 2011
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date September 29, 2010
First Posted Date November 22, 2010
Results First Submitted Date December 21, 2010
Results First Posted Date January 7, 2011
Last Update Posted Date January 13, 2011
Study Start Date August 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2011)
  • Visual Acuity (VA) [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures
 (submitted: November 19, 2010)
  • visual acuity [ Time Frame: after 18 weeks ]
  • Quality of life (NEI-VFQ25) [ Time Frame: every 6 months ]
  • Investigator´s assessment of efficacy [ Time Frame: after 18 weeks ]
  • lesion size [ Time Frame: after 18 weeks ]
  • change in activity of neovascular membrane [ Time Frame: after 18 weeks ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2010)
  • Time to First Adverse Event (AE) [ Time Frame: Baseline up to Month 24 or early termination ]
    Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.
  • Number of Participants With Complications Associated With Injection [ Time Frame: Baseline up to Month 24 or early termination ]
    Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.
  • Treatment Tolerability [ Time Frame: Month 24 or early termination ]
    Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.
  • Intraocular Pressure (IOP) [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ]
    IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.
  • Change in IOP Between Predose and Postdose Assessment [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ]
    IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.
  • IOP Mean Difference (Within a Participant) [ Time Frame: Baseline, every 6 weeks up to Month 24 or early termination ]
    Average predose minus postdose mean difference in IOP within a participant
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
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
Brief Summary 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.
Detailed Description Ophthalmologists who are experienced in doing intravitreal injections in Germany
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with neovascular age-related macular degeneration
Condition
  • Macular Degeneration
  • Age-related Macular Degeneration
  • Neovascular Macular Degeneration
Intervention 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.
Study Groups/Cohorts Macugen
Intervention: Drug: Pegaptanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 19, 2010)
1001
Original Actual Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with neovascular age-related macular degeneration

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01245387
Other Study ID Numbers A5751021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011