Macular Degeneration Clinical Trial
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
Verified date | November 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 501 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Pfizer Investigational Site | Bruxelles | |
Belgium | Pfizer Investigational Site | Charleroi | |
Belgium | Pfizer Investigational Site | Ieper | |
Belgium | Pfizer Investigational Site | Lier | |
Belgium | Pfizer Investigational Site | Turnhout | |
Cyprus | Pfizer Investigational Site | Lemesos | |
Czech Republic | Pfizer Investigational Site | Brno | |
Czech Republic | Pfizer Investigational Site | Hradec Kralove | |
Czech Republic | Pfizer Investigational Site | Plzen | |
Czech Republic | Pfizer Investigational Site | Praha 10 | |
Czech Republic | Pfizer Investigational Site | Praha 2 | |
Czech Republic | Pfizer Investigational Site | Praha 6 | |
Denmark | Pfizer Investigational Site | Soenderborg | |
France | Pfizer Investigational Site | Argonay | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Grenoble | |
France | Pfizer Investigational Site | Le Golfe Juan | |
France | Pfizer Investigational Site | Marseille cedex 08 | |
France | Pfizer Investigational Site | Rennes | |
Germany | Pfizer Investigational Site | Augsburg | |
Germany | Pfizer Investigational Site | Frankfurt | |
Germany | Pfizer Investigational Site | Karlsruhe | |
Germany | Pfizer Investigational Site | Konstanz | |
Germany | Pfizer Investigational Site | Ludwigshafen | |
Germany | Pfizer Investigational Site | Muenchen | |
Germany | Pfizer Investigational Site | Muenster | |
Germany | Pfizer Investigational Site | Weilheim | |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Heraklion | |
Greece | Pfizer Investigational Site | Heraklion | Crete |
Greece | Pfizer Investigational Site | Ioannina | |
Greece | Pfizer Investigational Site | Kavala | |
Greece | Pfizer Investigational Site | Nikea | Piraeus |
Greece | Pfizer Investigational Site | Thessaloniki | |
Greece | Pfizer Investigational Site | Thessaloniki | |
Ireland | Pfizer Investigational Site | Waterford | |
Italy | Pfizer Investigational Site | Arona, NO | |
Italy | Pfizer Investigational Site | Bologna | |
Italy | Pfizer Investigational Site | Cagliari | |
Italy | Pfizer Investigational Site | Monza, MI | |
Italy | Pfizer Investigational Site | Napoli | |
Italy | Pfizer Investigational Site | Pisa | |
Italy | Pfizer Investigational Site | Rieti | |
Italy | Pfizer Investigational Site | Siena | |
Poland | Pfizer Investigational Site | Bydgoszcz | |
Poland | Pfizer Investigational Site | Szczecin | |
Poland | Pfizer Investigational Site | Warszawa | |
Slovakia | Pfizer Investigational Site | Banska Bystrica | |
Slovakia | Pfizer Investigational Site | Bratislava | |
Slovakia | Pfizer Investigational Site | Bratislava | |
Slovakia | Pfizer Investigational Site | Kosice | |
Slovakia | Pfizer Investigational Site | Presov | |
Slovakia | Pfizer Investigational Site | Presov | |
Slovakia | Pfizer Investigational Site | Ruzomberok | |
Slovakia | Pfizer Investigational Site | Trencin | |
Slovakia | Pfizer Investigational Site | Zilina | |
Spain | Pfizer Investigational Site | Alcala de Henares | Madrid |
Spain | Pfizer Investigational Site | Madrid | |
Spain | Pfizer Investigational Site | Pamplona | Navarra |
Spain | Pfizer Investigational Site | Santa Cruz de Tenerife | |
Spain | Pfizer Investigational Site | Santiago de Compostela | A Coruña |
Spain | Pfizer Investigational Site | Valencia | |
Spain | Pfizer Investigational Site | Valencia | |
Spain | Pfizer Investigational Site | Valladolid | |
Sweden | Pfizer Investigational Site | Stockholm | |
Sweden | Pfizer Investigational Site | Västerås |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovakia, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | 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. | Baseline up to 2 years | Yes |
Primary | Incidence of POAEs Per Injection Reported by Gender (Females) | 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. | Baseline up to 2 years | Yes |
Secondary | Incidence of POAEs Per Injection Reported by Gender (Males) | 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. | Baseline up to 2 years | Yes |
Secondary | Incidence of POAEs Per Injection Reported by Age Group (= 50 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. | Baseline up to 2 years | Yes |
Secondary | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 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. | Baseline up to 2 years | Yes |
Secondary | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 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. | Baseline up to 2 years | Yes |
Secondary | Incidence of POAEs Per Injection Reported by Age Group (= 75 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. | Baseline up to 2 years | Yes |
Secondary | Number of Participants With Serious Hypersensitivity Reactions | 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. | Baseline up to 2 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
Completed |
NCT02540954 -
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
|
Phase 3 | |
Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
Completed |
NCT02510794 -
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT02181504 -
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
|
Phase 2 | |
Terminated |
NCT02228304 -
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT01204541 -
A Single-Center Pilot Study to Assess Macular Function
|
N/A | |
Completed |
NCT00769392 -
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
|
N/A | |
Completed |
NCT00536016 -
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
|
Phase 1 | |
Completed |
NCT00533520 -
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
|
Phase 4 | |
Withdrawn |
NCT00538538 -
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
|
Phase 1 | |
Terminated |
NCT00403442 -
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
|
Phase 1 | |
Recruiting |
NCT00157976 -
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
|
Phase 3 | |
Completed |
NCT00242580 -
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
|
Phase 3 | |
Completed |
NCT00239928 -
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT00211458 -
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
|
Phase 2 | |
Completed |
NCT00095433 -
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
|
Phase 3 | |
Completed |
NCT00006202 -
Lutein for Age-Related Macular Degeneration
|
Phase 2 |