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

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Macugen

• Registration Number: NCT00460408
• Lead Sponsor: Pfizer

Brief Summary

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

No comparator Patients with age-related macular degeneration

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-04-13
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-16
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2012-09-24
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-14
• Last Update Submitted: 2012-11-14
• Results First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

• Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

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Exclusion Criteria

• Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational study, no comparator	Macugen	Observational study of patients with AMD treated with Macugen, no comparator

Primary Outcome Measures

Name	Time	Method
Incidence of POAEs Per Injection Reported by Gender (Females)	Baseline up to 2 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.
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Baseline up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of POAEs Per Injection Reported by Gender (Males)	Baseline up to 2 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.
Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)	Baseline up to 2 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.
Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)	Baseline up to 2 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.
Number of Participants With Serious Hypersensitivity Reactions	Baseline up to 2 years	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.
Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)	Baseline up to 2 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.
Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)	Baseline up to 2 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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Västerås, Sweden