Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)

Eyetech Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Age-Related Macular Degeneration

Treatments

Drug: pegaptanib sodium (Macugen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00215670

EOP1006

Details and patient eligibility

About

The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.

Subfoveal CNV, secondary to AMD, w/ a total lesion size [including blood, scar/atrophy & neovascularization] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.

Patients of either sex, aged greater than or equal to 50 years.

Exclusion criteria

Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy & no more than 25% of the total lesion size may be made up of scarring or atrophy.

More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.