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

Study Overview
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Brief Summary
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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.

Official Title
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A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Macugen


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Patients participating in another clinical study with Macugen.
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 |
| --- | --- |
| 1<br>Patients who obtained reimbursement of Macugen. | Drug: Macugen<br>* Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)<br>* Other names: Pegaptanib sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Final Visit in Visual Acuity (VA) Score | 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. | Baseline, Month 24 or Early Termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in VA: Improvement | 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. | Months 3, 6, 9 and 12 | 
| Number of Participants With Change in VA: Stabilization | 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. | Months 3, 6, 9 and 12 | 
| Number of Participants With Change in VA: Worsening | 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. | Months 3, 6, 9 and 12 | 
| Duration of Treatment | 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). | Baseline up to 28.4 months | 
| Frequency of Macugen Administration | Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment. | Baseline up to 28.4 months | 
| Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments | Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit). | Months 3, 6, 9 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macugen Age-related macular degeneration (AMD) Observational study