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
Study Type
OBSERVATIONAL
Enrollment
1,001
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.
Visual Acuity (VA)
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).
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
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.
Time frame: Baseline, every 6 months up to Month 24 or early termination
Number of Participants With Investigator Assessments of Efficacy
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.
Time frame: Month 24 or early termination
Lesion Size (Number of Optic Disc Areas)
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 6
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 12
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 18
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 24
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 30
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 36
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 42
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 48
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 54
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 60
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 66
Number of Participants With a Change in Activity of Neovascular Membrane at 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.
Time frame: Week 72
Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
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.
Time frame: Month 24 or early termination
Number of Participants With Pigment Epithelial Detachment (PED) at 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.
Time frame: Baseline
Number of Participants With PED at 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.
Time frame: Week 6
Number of Participants With PED at 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.
Time frame: Week 12
Number of Participants With PED at 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.
Time frame: Week 18
Number of Participants With PED at 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.
Time frame: Week 24
Number of Participants With PED at 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.
Time frame: Week 30
Number of Participants With PED at 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.
Time frame: Week 36
Number of Participants With PED at 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.
Time frame: Week 42
Number of Participants With PED at 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.
Time frame: Week 48
Number of Participants With PED at 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.
Time frame: Week 54
Number of Participants With PED at Last Visit
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.
Time frame: Month 24 or early termination
Central Retinal Thickness
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).
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Baseline
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 6
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 12
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 18
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 24
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 30
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 36
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 42
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 48
Number of Participants With Angiographic Subtype Reported at 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).
Time frame: Week 54
Number of Participants With Angiographic Subtype Reported at Last Visit
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.
Time frame: Month 24 or early termination