Clinical trial NCT01245387: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Age-related Macular Degeneration
Neovascular Macular Degeneration
Keywords: prospective
observational
Phase 4
non-interventional
open-label
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neovascular age-related macular degeneration

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

Eligibility criteria: Inclusion Criteria:

* patients with neovascular age-related macular degeneration

Exclusion Criteria:

* none

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
measure: Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
timeFrame: Baseline, every 6 months up to Month 24 or early termination
measure: Number of Participants With Investigator Assessments of Efficacy
timeFrame: Month 24 or early termination
measure: Lesion Size (Number of Optic Disc Areas)
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
timeFrame: Week 6
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
timeFrame: Week 12
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
timeFrame: Week 18
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
timeFrame: Week 24
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
timeFrame: Week 30
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
timeFrame: Week 36
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
timeFrame: Week 42
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
timeFrame: Week 48
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
timeFrame: Week 54
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
timeFrame: Week 60
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
timeFrame: Week 66
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
timeFrame: Week 72
measure: Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
timeFrame: Month 24 or early termination
measure: Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
timeFrame: Baseline
measure: Number of Participants With PED at Week 6
timeFrame: Week 6
measure: Number of Participants With PED at Week 12
timeFrame: Week 12
measure: Number of Participants With PED at Week 18
timeFrame: Week 18
measure: Number of Participants With PED at Week 24
timeFrame: Week 24
measure: Number of Participants With PED at Week 30
timeFrame: Week 30
measure: Number of Participants With PED at Week 36
timeFrame: Week 36
measure: Number of Participants With PED at Week 42
timeFrame: Week 42
measure: Number of Participants With PED at Week 48
timeFrame: Week 48
measure: Number of Participants With PED at Week 54
timeFrame: Week 54
measure: Number of Participants With PED at Last Visit
timeFrame: Month 24 or early termination
measure: Central Retinal Thickness
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
measure: Number of Participants With Angiographic Subtype Reported at Baseline
timeFrame: Baseline
measure: Number of Participants With Angiographic Subtype Reported at Week 6
timeFrame: Week 6
measure: Number of Participants With Angiographic Subtype Reported at Week 12
timeFrame: Week 12
measure: Number of Participants With Angiographic Subtype Reported at Week 18
timeFrame: Week 18
measure: Number of Participants With Angiographic Subtype Reported at Week 24
timeFrame: Week 24
measure: Number of Participants With Angiographic Subtype Reported at Week 30
timeFrame: Week 30
measure: Number of Participants With Angiographic Subtype Reported at Week 36
timeFrame: Week 36
measure: Number of Participants With Angiographic Subtype Reported at Week 42
timeFrame: Week 42
measure: Number of Participants With Angiographic Subtype Reported at Week 48
timeFrame: Week 48
measure: Number of Participants With Angiographic Subtype Reported at Week 54
timeFrame: Week 54
measure: Number of Participants With Angiographic Subtype Reported at Last Visit
timeFrame: Month 24 or early termination
Secondary outcomes:
Other outcomes:
measure: Time to First Adverse Event (AE)
timeFrame: Baseline up to Month 24 or early termination
measure: Number of Participants With Complications Associated With Injection
timeFrame: Baseline up to Month 24 or early termination
measure: Treatment Tolerability
timeFrame: Month 24 or early termination
measure: Intraocular Pressure (IOP)
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
measure: Change in IOP Between Predose and Postdose Assessment
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
measure: IOP Mean Difference (Within a Participant)
timeFrame: Baseline, every 6 weeks up to Month 24 or early termination
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: