Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

NCT00460408 | Completed Results

• 1 other identifier: A5751019
• Study Type: observational
• Target: 501
• Locations: 13 countries
• Sites: 68

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.

Conditions

Macular Degeneration

Keywords

Macular degeneration; Safety; Non-interventional; Non-randomized

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Incidence of POAEs Per Injection Reported by Gender (Males)

  Baseline up to 2 years

• Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)

  Baseline up to 2 years

• Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)

  Baseline up to 2 years

• Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)

  Baseline up to 2 years

• Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)

  Baseline up to 2 years

Study Arms (1)

Observational study, no comparator

Observational study of patients with AMD treated with Macugen, no comparator

Drug: Macugen

Interventions

Macugen DRUG

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

Observational study, no comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with age-related macular degeneration

You may qualify if:

• Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

You may not qualify if:

• Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (68)

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Charleroi, 6000, Belgium

Location

Pfizer Investigational Site

Ieper, 8900, Belgium

Location

Pfizer Investigational Site

Lier, 2500, Belgium

Location

Pfizer Investigational Site

Turnhout, 2300, Belgium

Location

Pfizer Investigational Site

Limassol, 1430, Cyprus

Location

Pfizer Investigational Site

Brno, 625 00, Czechia

Location

Pfizer Investigational Site

Hradec Králové, 500 05, Czechia

Location

Pfizer Investigational Site

Pilsen, 304 60, Czechia

Location

Pfizer Investigational Site

Prague, 10034, Czechia

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Prague, 169 02, Czechia

Location

Pfizer Investigational Site

Sønderborg, 6400, Denmark

Location

Pfizer Investigational Site

Argonay, 74370, France

Location

Pfizer Investigational Site

Dijon, 21055, France

Location

Pfizer Investigational Site

Grenoble, 38100, France

Location

Pfizer Investigational Site

Le Golfe Juan, 06220, France

Location

Pfizer Investigational Site

Marseille, 13285, France

Location

Pfizer Investigational Site

Rennes, 35033, France

Location

Pfizer Investigational Site

Augsburg, 86156, Germany

Location

Pfizer Investigational Site

Frankfurt, 60318, Germany

Location

Pfizer Investigational Site

Karlsruhe, 76137, Germany

Location

Pfizer Investigational Site

Konstanz, 78462, Germany

Location

Pfizer Investigational Site

Ludwigshafen, 67063, Germany

Location

Pfizer Investigational Site

München, 81675, Germany

Location

Pfizer Investigational Site

Münster, 48145, Germany

Location

Pfizer Investigational Site

Weilheim, 82362, Germany

Location

Pfizer Investigational Site

Heraklion, Crete, 71110, Greece

Location

Pfizer Investigational Site

Nikaia, Piraeus, 18454, Greece

Location

Pfizer Investigational Site

Athens, 10672, Greece

Location

Pfizer Investigational Site

Athens, 115 27, Greece

Location

Pfizer Investigational Site

Athens, 11526, Greece

Location

Pfizer Investigational Site

Heraklion, 71001, Greece

Location

Pfizer Investigational Site

Ioannina, 45500, Greece

Location

Pfizer Investigational Site

Kavala, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54636, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54642, Greece

Location

Pfizer Investigational Site

Waterford, Ireland

Location

Pfizer Investigational Site

Arona, NO, 28041, Italy

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Cagliari, 09100, Italy

Location

Pfizer Investigational Site

Monza, MI, 20052, Italy

Location

Pfizer Investigational Site

Napoli, 80131, Italy

Location

Pfizer Investigational Site

Pisa, 56124, Italy

Location

Pfizer Investigational Site

Rieti, 02100, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Bydgoszcz, 85 - 094, Poland

Location

Pfizer Investigational Site

Szczecin, 70 - 111, Poland

Location

Pfizer Investigational Site

Warsaw, 04-141, Poland

Location

Pfizer Investigational Site

Banská Bystrica, 975 17, Slovakia

Location

Pfizer Investigational Site

Bratislava, 826 06, Slovakia

Location

Pfizer Investigational Site

Bratislava, 851 03, Slovakia

Location

Pfizer Investigational Site

Košice, 041 66, Slovakia

Location

Pfizer Investigational Site

Prešov, 08001, Slovakia

Location

Pfizer Investigational Site

Prešov, 081 81, Slovakia

Location

Pfizer Investigational Site

Ružomberok, 03426, Slovakia

Location

Pfizer Investigational Site

Trenčín, 911 71, Slovakia

Location

Pfizer Investigational Site

Žilina, 012 07, Slovakia

Location

Pfizer Investigational Site

Santiago de Compostela, A Coruña, 15706, Spain

Location

Pfizer Investigational Site

Alcalá de Henares, Madrid, 28805, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28040, Spain

Location

Pfizer Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Pfizer Investigational Site

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46015, Spain

Location

Pfizer Investigational Site

Valladolid, Valladolid, 47010, Spain

Location

Pfizer Investigational Site

Stockholm, 118 83, Sweden

Location

Pfizer Investigational Site

Västerås, 721 89, Sweden

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: August 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 11, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-11

Locations

ES (8); BE (5); SL (9); PL (3); GR (10); FR (6); DK (1); IE (1); IT (8); CZ (6); DE (8); SE (2); CY (1)