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: 8.1Level: LLTClassification code 10025411Term: Macular degeneration senile
- Registration Number
- EUCTR2005-004514-32-GB
- Lead Sponsor
- Pfizer Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
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 in the study eye.
3. Baseline protocol refraction visual acuity of = 20/320 or better than 25 EDTRS letters in the study eye.
4. Total lesion area in the study eye (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 protocol refraction 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
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 in the study eye.
3. Subjects with fibrosis/scar or atrophy representing >25% of the total lesion size in the study eye.
4. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. 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 in the study eye.
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 in the study eye.
8. Previous posterior vitrectomy or submacular surgery in the study eye.
9. Previous or concomitant therapy with intravitreous corticosteroids or a therapeutic
intraocular implant device in the study eye.
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 in the study eye.
12. Diabetic retinopathy.
13. Uncontrolled ocular hypertension or uncontrolled glaucoma in the study eye.
14. Previous therapeutic radiation in the region of the study eye.
15. Any major surgical procedure(s) within the one month before study enrollment.
16. Stroke (within the 12 months before study 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 (i.e. fluorescein or indocyanine green) 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
- Secondary Outcome Measures
Name Time Method