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

Study Overview
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Brief Summary
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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
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Ophthalmologists who are experienced in doing intravitreal injections in Germany

Official Title
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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

Conditions
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Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration

Intervention / Treatment
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* Drug: Pegaptanib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with neovascular age-related macular degeneration Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macugen<br> | Drug: Pegaptanib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | Month 24 or early termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective, observational, Phase 4, non-interventional, open-label