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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00460408
First received: April 13, 2007
Last updated: November 14, 2012
Last verified: November 2012

April 13, 2007
November 14, 2012
August 2006
February 2012   (final data collection date for primary outcome measure)
  • Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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.
  • Incidence of POAEs Per Injection Reported by Gender (Females) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Complete list of historical versions of study NCT00460408 on ClinicalTrials.gov Archive Site
  • Incidence of POAEs Per Injection Reported by Gender (Males) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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 (≥ 75 Years) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: Yes ]
    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.
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Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
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

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

Observational
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

Patients with age-related macular degeneration

Macular Degeneration
Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
Observational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
Intervention: Drug: Macugen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Belgium,   Cyprus,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Sweden,   Poland,   Slovakia,   Spain
 
NCT00460408
A5751019
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP