Macugen Observational Study

Pfizer

Status: Terminated

Conditions: Macular Degeneration; Vascular Endothelial Growth Factor

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00735943

A5751031

Details and patient eligibility

About

The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year

Full description

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.

If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.

The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

Exclusion criteria

• Active or suspected ocular or periocular infection.
• Known hypersensitivity to pegaptanib sodium or any other excipient in this product.