Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

Study Overview
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Brief Summary
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The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

Detailed Description
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No comparator Patients with age-related macular degeneration

Official Title
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European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Macugen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neovascular AMD patients who are eligible for Macugen therapy based on the approved label Exclusion Criteria: Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

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 |
| --- | --- |
| Observational study, no comparator<br>Observational study of patients with AMD treated with Macugen, no comparator | Drug: Macugen<br>* Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Incidence of POAEs Per Injection Reported by Gender (Females) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POAEs Per Injection Reported by Gender (Males) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years | 
| Number of Participants With Serious Hypersensitivity Reactions | Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms. | Baseline up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular degeneration, Safety, Non-interventional, Non-randomized