Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00460408
Other study ID # A5751019
Secondary ID
Status Completed
Phase N/A
First received April 13, 2007
Last updated November 14, 2012
Start date August 2006
Est. completion date February 2012

Study information

Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Description:

No comparator Patients with age-related macular degeneration


Recruitment information / eligibility

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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Cyprus,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Poland,  Slovakia,  Spain,  Sweden, 

Outcome

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
See also
  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