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
  Purpose

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 Intervention
Macular Degeneration
Drug: Macugen

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 501
Study Start Date: August 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

No comparator Patients with age-related macular degeneration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460408

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00460408     History of Changes
Other Study ID Numbers: A5751019
Study First Received: April 13, 2007
Results First Received: September 24, 2012
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014