Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00460408
First received: April 13, 2007
Last updated: November 14, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Pegaptanib sodium
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460408
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| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Charleroi, Belgium, 6000 | |
| Pfizer Investigational Site | |
| Ieper, Belgium, 8900 | |
| Pfizer Investigational Site | |
| Lier, Belgium, 2500 | |
| Pfizer Investigational Site | |
| Turnhout, Belgium, 2300 | |
| Cyprus | |
| Pfizer Investigational Site | |
| Lemesos, Cyprus, 1430 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 625 00 | |
| Pfizer Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Pfizer Investigational Site | |
| Plzen, Czech Republic, 304 60 | |
| Pfizer Investigational Site | |
| Praha 10, Czech Republic, 10034 | |
| Pfizer Investigational Site | |
| Praha 2, Czech Republic, 128 08 | |
| Pfizer Investigational Site | |
| Praha 6, Czech Republic, 169 02 | |
| Denmark | |
| Pfizer Investigational Site | |
| Soenderborg, Denmark, 6400 | |
| France | |
| Pfizer Investigational Site | |
| Argonay, France, 74370 | |
| Pfizer Investigational Site | |
| Dijon, France, 21055 | |
| Pfizer Investigational Site | |
| Grenoble, France, 38100 | |
| Pfizer Investigational Site | |
| Le Golfe Juan, France, 06220 | |
| Pfizer Investigational Site | |
| Marseille cedex 08, France, 13285 | |
| Pfizer Investigational Site | |
| Rennes, France, 35033 | |
| Germany | |
| Pfizer Investigational Site | |
| Augsburg, Germany, 86156 | |
| Pfizer Investigational Site | |
| Frankfurt, Germany, 60318 | |
| Pfizer Investigational Site | |
| Karlsruhe, Germany, 76137 | |
| Pfizer Investigational Site | |
| Konstanz, Germany, 78462 | |
| Pfizer Investigational Site | |
| Ludwigshafen, Germany, 67063 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81675 | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48145 | |
| Pfizer Investigational Site | |
| Weilheim, Germany, 82362 | |
| Greece | |
| Pfizer Investigational Site | |
| Heraklion, Crete, Greece, 71110 | |
| Pfizer Investigational Site | |
| Nikea, Piraeus, Greece, 18454 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 27 | |
| Pfizer Investigational Site | |
| Athens, Greece, 10672 | |
| Pfizer Investigational Site | |
| Athens, Greece, 11526 | |
| Pfizer Investigational Site | |
| Heraklion, Greece, 71001 | |
| Pfizer Investigational Site | |
| Ioannina, Greece, 45500 | |
| Pfizer Investigational Site | |
| Kavala, Greece | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 54642 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 54636 | |
| Ireland | |
| Pfizer Investigational Site | |
| Waterford, Ireland | |
| Italy | |
| Pfizer Investigational Site | |
| Arona, NO, Italy, 28041 | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | |
| Cagliari, Italy, 09100 | |
| Pfizer Investigational Site | |
| Monza, MI, Italy, 20052 | |
| Pfizer Investigational Site | |
| Napoli, Italy, 80131 | |
| Pfizer Investigational Site | |
| Pisa, Italy, 56124 | |
| Pfizer Investigational Site | |
| Rieti, Italy, 02100 | |
| Pfizer Investigational Site | |
| Siena, Italy, 53100 | |
| Poland | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85 - 094 | |
| Pfizer Investigational Site | |
| Szczecin, Poland, 70 - 111 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 04-141 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 851 03 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 826 06 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 041 66 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 081 81 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 08001 | |
| Pfizer Investigational Site | |
| Ruzomberok, Slovakia, 03426 | |
| Pfizer Investigational Site | |
| Trencin, Slovakia, 911 71 | |
| Pfizer Investigational Site | |
| Zilina, Slovakia, 012 07 | |
| Spain | |
| Pfizer Investigational Site | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Pfizer Investigational Site | |
| Alcala de Henares, Madrid, Spain, 28805 | |
| Pfizer Investigational Site | |
| Pamplona, Navarra, Spain, 31008 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Santa Cruz de Tenerife, Spain, 38010 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46015 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46014 | |
| Pfizer Investigational Site | |
| Valladolid, Spain, 47010 | |
| Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 118 83 | |
| Pfizer Investigational Site | |
| Västerås, Sweden, 721 89 | |
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 May 16, 2013