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Completed

NCT Number: NCT01245387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with neovascular age-related macular degeneration

Exclusion criteria

  • none

Treatment and study plan

Pegaptanib

Drug

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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).

  38. 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).

  39. 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).

  40. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Treatment Tolerability

    Time frame: Month 24 or early termination

    Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: MACULA

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2010
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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