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Trial record 1 of 1 for:    NCT00460408
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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

Tracking Information
First Submitted Date April 13, 2007
First Posted Date April 16, 2007
Results First Submitted Date September 24, 2012
Results First Posted Date December 11, 2012
Last Update Posted Date December 11, 2012
Study Start Date August 2006
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2012)
  • 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.
  • 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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00460408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
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
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with age-related macular degeneration
Condition Macular Degeneration
Intervention Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
Study Groups/Cohorts Observational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
Intervention: Drug: Macugen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 24, 2012)
501
Original Enrollment
 (submitted: April 13, 2007)
550
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Cyprus,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Poland,   Slovakia,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT00460408
Other Study ID Numbers A5751019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2012