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)

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

• Registration Number: EUCTR2005-004514-32-BE
• Lead Sponsor: Pfizer S.A. Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-09
• Last Update Posted: 7 October 2014

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 within 14 days prior to the first injection
Note: 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. Adequate hematological function: hemoglobin =10g/dL; platelet count =130 x 109/L; WBC = 3.8 x 109/L.
4. Adequate renal function: serum creatinine =2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN).
5. Adequate liver function: serum bilirubin =1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN.
6. Provide written informed consent prior to conducting any study related procedures
7. Able to adhere to the treatment/visit plan.

General Ophthalmic Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Note: If both eyes meet eligibility criteria, the right eye is to be selected as the study eye. Only one eye will be allowed to be included in this study.
1. Evidence of neovascular AMD in at least one eye, in subjects with bilateral neovascular AMD would be eligible for treatment.
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.

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 high speed ICG-A 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 or any retinal or subretinal hemorrhage(s) measuring =1/2 disc area in aggregate size.
4. Absence of lipid exudation, subfoveal fibrosis, subfoveal atrophy or retinal pigment epithelial detachment.
5. Baseline visual acuity = 54 letters or equivalent (20/80 Snellen visual acuity) with vision loss < 10 ETDRS letters or equivalent (< 2 Snellen visual acuity) during three months prior to enrollment.
6. Total area of the lesion (including associated blood and CNV) must be = 12 disc areas.

Inclusion Criteria for Subjects with Established CNV Lesions:
1.Classic CNV on FA representing > 50% of the total lesions area 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
b. subfoveal hemorrhage or any retinal or subretinal hemorrhage(s) measuring =1/2 disc area in aggregate size.
c. Lipid exudation
d. vision loss =10 ETDRS letters or equivalent (= 2 Snellen visual acuity) during three months prior to enrollment.
3. Total lesion size (including associated blood, CNV, fibrosis and atrophy) must be =12 disc areas.
Are the trial subjects under 18?
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 Numbe

Exclusion Criteria

1.Any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye.
2.Previous treatment for CNV secondary to AMD.
3.Subjects having subfoveal fibrosis, subfoveal atrophy, or subfoveal hemorrhage >50% of the total lesion area.
4.Subjects with fibrosis or atrophy representing > 25% of the total lesion size.
5.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.
6.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.
7.Any intraocular surgery or thermal laser to the study eye within three months of enrollment.
8.Any ocular or periocular infection within the past four weeks.
9.Previous posterior vitrectomy or submacular surgery
10.Previous or concomitant therapy with intravitreous corticosteroids or a therapeutic intraocular implant device.
11.Previous or concomitant therapy with another investigational agent to treat AMD, with the exception of oral supplements of vitamins and minerals.
12.Presence of pigment epithelial tears or rips.
13.Previous therapeutic radiation in the region of the study eye.
14.Any major surgical procedure(s) within one month of enrollment.
15.Stroke (within 12 months of enrollment).
16.Diabetic retinopathy
17.Uncontrolled ocular hypertension or glaucoma in the study eye
18.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.
19.Any treatment with an investigational agent in the past 60 days for any condition.
20.Known serious allergies to the fluorescein dye used in angiography or to the components of Macugen® formulation.

Study & Design

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