A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Macugen

• Registration Number: NCT00549055
• Lead Sponsor: Pfizer

Brief Summary

To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-25
• Study Start: 2007-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-01
• Results First Submitted QC: 2010-10-01
• Results First Posted: 2010-10-27
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
• Patients having received at least 1 Macugen injection
• Treatment naive patients, or patients having received conventional therapy
• Patients having signed and dated informed consent.

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Exclusion Criteria

• Patients participating in another clinical study with Macugen.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Macugen	Patients who obtained reimbursement of Macugen.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Final Visit in Visual Acuity (VA) Score	Baseline, Month 24 or Early Termination	Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Change in VA: Improvement	Months 3, 6, 9 and 12	Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.
Number of Participants With Change in VA: Worsening	Months 3, 6, 9 and 12	Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Number of Participants With Change in VA: Stabilization	Months 3, 6, 9 and 12	Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Duration of Treatment	Baseline up to 28.4 months	Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).
Frequency of Macugen Administration	Baseline up to 28.4 months	Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.
Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments	Months 3, 6, 9 and 12	Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Liege, Belgium