An exploratory randomized, double-masked, multi-center, multi-dose comparative trial, in parallel groups, to explore the safety and efficacy of three different doses of intravitreous injections of pegaptanib sodium given every 6 weeks for 102 weeks, in subjects with subfoveal neovascular Age-Related Macular Degeneration (AMD)

Conditions: Age-Related Macular Degeneration (AMD)
MedDRA version: 8.0Level: LLTClassification code 10064930

Registration Number: EUCTR2006-000722-31-PT

Lead Sponsor: (OSI) Eyetech, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 262

Inclusion Criteria

AOphthalmic Criteria
1Subfoveal choroidal neovascularization (CNV) due to AMD.
2Best corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/800 in the fellow eye.
3Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be < 12 Disc Areas, of which at least 50% must be active CNV.
4For subjects with occult with no classic CNV, there must be the presence of subretinal hemorrhage.
5Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
6Intraocular pressure (IOP) of 21mmHg or less.
7Normal ERG result (The first 182 subjects administered ERG at baseline) and corneal endothelial cell density of 1500 cells/mm2 or more.

B General Criteria
1Subjects of either gender aged ? 50 years.
2Performance Status ? 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale (See Appendix 17.4)
3Normal electrocardiogram (ECG) or clinically non-significant changes.
4Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
5Adequate hematological function: hemoglobin ? 10g/dL; platelet count ? 130 x 109/L; WBC ? 3.8 x 109/L.
6Adequate renal function: serum creatinine ? 2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN).
7Adequate liver function: serum bilirubin ? 1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN.
8Provide written informed consent.
9Ability to return for all trial visits.

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

1Any prior PDT with Visudyne? or thermal laser to the study eye.
2More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded. Subjects should also be excluded in the case of subfoveal hemorrhage in the study eye if the size of the hemorrhage is either = 50% of the total lesion area or = 1 disc area.
3Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography. Subjects should not be entered if there is likelihood that they will require cataract surgery in either eye within the following 2 years.
4Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters or more negative, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
5Any intraocular surgery to either eye within 3 months of trial entry. Previous history of filtering surgery (e.g. trabeculectomy) or the placement of a glaucoma drainage device.
6Any ocular or periocular infection in the past 4 weeks.
7Previous posterior vitrectomy.
8Previous or concomitant therapy with intravitreous corticosteroids.
9Previous or concomitant therapy with another investigational agent to treat AMD, except oral supplements of vitamins and minerals.
10Presence of pigment epithelial tears or rips.
11Any underlying pathology that may adversely affect ERG or corneal assessment.
12Any of the following underlying diseases including:
•Diabetic retinopathy.
•History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 17.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment.
•History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
•Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
•Stroke (within 12 months of trial entry).
•Any major surgical procedure within one month of trial entry.
13Previous therapeutic radiation in the region of the study eye.
14Any treatment with an investigational agent in the past 60 days for any condition.
15Known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation.
16Baseline differences on ERG measurements of greater than 20% between the two eyes.
17A baseline difference in endothelial cell counts of greater than 10% between the two eyes. Previous history of corneal transplant in the study or non-study eye.