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.
No comparator Patients with age-related macular degeneration
Study Type
OBSERVATIONAL
Enrollment
501
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
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.
Time frame: 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.
Time frame: Baseline up to 2 years
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.
Time frame: 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.
Time frame: 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.
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Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Charleroi, Belgium
Pfizer Investigational Site
Ieper, Belgium
Pfizer Investigational Site
Lier, Belgium
Pfizer Investigational Site
Turnhout, Belgium
Pfizer Investigational Site
Limassol, Cyprus
Pfizer Investigational Site
Brno, Czechia
Pfizer Investigational Site
Hradec Králové, Czechia
Pfizer Investigational Site
Pilsen, Czechia
Pfizer Investigational Site
Prague, Czechia
...and 58 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 2 years