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

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ClinicalTrials.gov Identifier: NCT00460408
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Macular Degeneration Drug: Macugen

Detailed Description:
No comparator Patients with age-related macular degeneration

Study Type : Observational
Actual Enrollment : 501 participants
Time Perspective: Prospective
Official 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
Study Start Date : August 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Observational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with age-related macular degeneration
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460408


  Show 68 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00460408     History of Changes
Other Study ID Numbers: A5751019
First Posted: April 16, 2007    Key Record Dates
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: November 2012

Keywords provided by Pfizer:
Macular degeneration
Safety
Non-interventional
Non-randomized

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases