Skip to main content
OpenTrials
Completed

NCT Number: NCT00460408

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Brussels, Belgium

Loading trial locations.

About this study

No comparator Patients with age-related macular degeneration

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Macugen

Drug

Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.

Primary outcomes

  1. Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection

    Time frame: 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.

  2. Incidence of POAEs Per Injection Reported by Gender (Females)

    Time frame: 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.

Secondary outcomes

  1. Incidence of POAEs Per Injection Reported by Gender (Males)

    Time frame: 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.

  2. Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)

    Time frame: 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.

  3. Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)

    Time frame: 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.

  4. Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)

    Time frame: 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.

  5. Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)

    Time frame: 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.

  6. Number of Participants With Serious Hypersensitivity Reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2007
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.