A 102-Week, open label, multicenter trial to investigate the efficacy of macugen for the preservation of visual function in subjects with neovascular age-related macular degeneration (AMD) and to assess the benefit of treating early choroidal neovascularization (CNV) - N/A

• Conditions: Age related macular degeneration (AMD); MedDRA version: 8Level: LLTClassification code 10025411

• Registration Number: EUCTR2005-004514-32-DK
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-03
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Subjects of either gender, aged = 50 years.
2. Women must be post-menopausal (at least 24 months without a menstrual period) or be surgically sterile or if of childbearing potential, use two forms of contraception (i.e. abstinence, having a vasectomized partner, ongoing use of an approved oral, injectable or implanted contraceptive, a barrier method, or an IUD). If of childbearing potential, a negative urine pregnancy test must be performed at Visit 2, prior to the first injection. The two forms of effective contraception must be implemented throughout the duration of the study and for at least 60 days following the last dose of study medication.
3. Provide written informed consent prior to conducting any study related procedures
4. Able to adhere to the treatment/visit plan and comply with study requirements, i.e. telephone access for Call Center, etc.

General Ophthalmic Inclusion Criteria:
1. Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment in the study and designated as the study eye.
2.Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
3. Baseline visual acuity of = 20/320 or better than 25 EDTRS letters in the study eye.
4. Total lesion area (including CNV and associated lesion components) must be =12 disc areas.

Inclusion Criteria for Subjects with Early CNV Lesions:
1. Visual symptoms (i.e., blurred vision, visual loss, metamorphopsia, scotoma, etc) secondary to neovascular AMD.
2. Evidence of CNV demonstrated by ICG-A, where available, or CNV defined by FA as occult with no classic to occult with classic representing < 50% of the total lesion size.
3. Absence of subfoveal hemorrhage
4. Absence of any hemorrhage(s) measuring =1/2 disc area in aggregate size.
5. Absence of lipid exudation
6. Absence of fibrosis/scar or atrophy within the lesion
7. Absence of retinal pigment epithelial detachment (serous or fibrovascular)
8. Baseline visual acuity =54 letters or equivalent (20/80 Snellen visual acuity).

Inclusion Criteria for Subjects with Established CNV Lesions:
1.Classic CNV on FA representing =50% of the total lesion size OR
2. Occult with no classic to occult with a classic representing < 50% of the total CNV lesion size on FA demonstrating either of the following
a. retinal pigment epithelial detachment (serous or fibrovascular)
b. Any fibrosis/scar or atrophy within the lesion
c. subfoveal hemorrhage
d. Any hemorrhage(s) measuring =1/2 disc area in aggregate size.
e. Lipid exudation

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

1.Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye.
2.Subjects having subfoveal fibrosis/scar , subfoveal atrophy, or any hemorrhage >50% of the total lesion area.
3.Subjects with fibrosis/scar or atrophy representing > 25% of the total lesion size.
4.Significant 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 within the following two years.
5.Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters (or more negative), or axial length of = 25mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis.
6.Any intraocular surgery or thermal laser to the study eye within three months of enrollment.
7.Any ocular or periocular infection within the past four weeks.
8.Previous posterior vitrectomy or submacular surgery
9.Previous or concomitant therapy with intravitreous corticosteroids or a therapeutic intraocular implant device.
10.Previous or concomitant therapy with another investigational agent to treat AMD, with the exception of oral supplements of vitamins and minerals.
11.Presence of pigment epithelial tears or rips.
12. Diabetic retinopathy.
13. Uncontrolled ocular hypertension or glaucoma in the study eye.
14.Previous therapeutic radiation in the region of the study eye.
15.Any major surgical procedure(s) within one month of enrollment.
16.Stroke (within 12 months of enrollment).
17.Any of the following underlying diseases:
- History or evidence of severe cardiac disease, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
18. Any condition, including findings in the medical history or in the pre-study assessments that, in the opinion of the investigator, constitute a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct, evaluation or completion of the study period.
19.Any treatment with an investigational agent in the past 60 days for any condition.
20.Known serious allergies to dyes used in angiography the components of Macugen® formulation or topical agents used in the intravitreal injection procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of Macugen 0.3 mg for the preservation of vision in subjects with early CNV lesions and established CNV lesions. ;Secondary Objective: To assess the efficacy of Macugen 0.3 mg for the preservation of visual function and quality of life measurements in subjects with neovascular AMD.To assess the safety of Macugen 0.3 mg in subjects with early CNV lesions and established CNV lesions.;Primary end point(s): The mean change in distance visual acuity from baseline to week 54 in subjects with early CNV lesions and established CNV lesions by assessing best corrected distance visual acuity as measured by EDTRS score.