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

Age-related Macular Degeneration Clinical Trial

— MACULA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245387
• Other study ID #: A5751021
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: January 12, 2011
• Start date: August 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with neovascular age-related macular degeneration

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Neovascular Macular Degeneration
• Wet 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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