Neovascular Age-related Macular Degeneration
Conditions
Keywords
A5751025
Brief summary
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.
Detailed description
Open-label, non-comparative, non-interventional study
Interventions
DRUGMacugen
Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have at least one eye which was diagnosed with neovascular degeneration
Exclusion criteria
* Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in visual acuity in the study eye at 6 months from baseline | 6 months |
Outcome results
None listed