An open label, non-comparative protocol for the use of pegaptanib sodium injection every 6 weeks in patients with exudative age-related macular degeneration (AMD).

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Ophthalmic Criteria
1. Best corrected visual acuity in the study eye worse than 20/40.
2. Subfoveal choroidal neovascularization, secondary to age related macular
degeneration, with a total lesion size [including blood, scar/atrophy &
neovascularization] of < 12 total disc areas, of which at least 50% must be active
CNV.
3. Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
4. Intraocular pressure of 23mmHg or less.

General Criteria
1. Patients of either gender, aged ?50 years.
2. Women must be using two forms of effective contraception, be post-menopausal
for at least 12 months prior to study entry, or surgically sterile. If of child-bearing
potential, a serum pregnancy test must be performed within 48 hours prior to
treatment and the result made available prior to treatment initiation. The two
forms of effective contraception must be implemented during the study and for at
least 60 days following the last dose of test medication.
3. Patients have completed participation in the other Macugen AMD study.
4. Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be eligible for treatment if any of the following criteria are present systemically or in the study eye:

1. Any subfoveal scarring or atrophy and no more than 25% of the total lesion size
may be made up of scarring or atrophy.
2. Patients who are eligible for any other of the Sponsor’s ongoing AMD studies still
open to enrollment.
3. Presence of other causes of choroidal neovascularization, including pathologic
myopia (spherical equivalent of –8 diopters or more, or axial length of 25mm or
more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture
and multifocal choroiditis.
4. Any of the following underlying diseases including:
- History or evidence of severe cardiac disease e.g. NYHA Functional Class III
or IV (e.g. marked limitation of activity due to fatigue, palpitation or dyspnea,
or worse), myocardial infarction within 6 months, ventricular tachyarrythmias
requiring ongoing treatment or unstable angina.
- Stroke (within 12 months of study entry)
- Acute ocular or periocular infection
5. Known serious allergies to the fluorescein dye used in angiography (and
indocyanine green if used) or to the components of Pegaptanib sodium
formulation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): There are no efficacy end points;Main Objective: To provide Pegaptanib Sodium Injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD who have previously enrolled in a Macugen study. . Patients will continue to be treated under this protocol until such time as the product becomes commercially available or the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist.

Secondary Outcome Measures

Name	Time	Method

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Eyetech Pharamceuticals Inc

Updated 5/1/2012