A phase 3B, randomised, active controlled, double-masked, single dummy, multi-center comparative trial, in parallel groups, to compare the safety and efficacy of intravitreous injections of Macugen™ given every 6 weeks for 54 weeks (to be extended to 102 weeks as indicated) plus sham photodynamic therapy (PDT), to Macugen™ plus PDT with Visudyne®, in subjects with predominantly classic subfoveal chorodial neovascularization (CNV) secondary to age-related macular degeneration (AMD).
- Conditions
- Exudative Age Related Macular Degeneration (AMD)
- Registration Number
- EUCTR2004-004867-31-ES
- Lead Sponsor
- Eyetech Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
Ophthalmic Criteria
1. Subfoveal choroidal neovascularization (CNV) due to AMD.
2. Predominantly classic lesion composition.
3. Best corrected visual acuity in the study eye between 20/40 and 20/200, and better or equal to 20/800 in the fellow eye.
4. The greatest linear dimension of the lesion (including blood, neovascularization, and scar/atrophy) must be >5,400 microns and the most nasal part of the lesion must be at least 200 microns from the temporal edge of the optic disc. At least 50% of the total lesion size must be CNV (classic CNV plus any occult CNV).
5. The total area of any lesion components other than CNV, such as subretinal hemorrhage must comprise less than 50% of total lesion size.
6. Clear ocular media and adequate papillary dilatation to permit good quality stereoscopic fundus photography.
7. Intraocular pressure (IOP) of 21mmHg or less.
General Criteria
1. Subjects of either gender, aged ³ 50 years.
2. Performance Status £ 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale.
3. Normal electrocardiogram (ECG) or clinically non-significant changes.
4. Women 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.
5. Adequate haematological function: haemoglobin ³10g/dL; platelet count ³ 130 x 109/L; WBC ³ 3.8 x 109/L.
6. Adequate renal function: serum creatinine £ 2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN).
7. Adequate liver function: serum bilirubin £ 1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN.
8. Provide written informed consent.
9. Ability 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
Subjects will not be eligible for the trial if patients cannot attend all study required visits, or if any of the following criteria are present systemically or in the study eye:
1. Previous subfoveal and non foveal thermal laser therapy.
2. Any prior PDT with VisudyneÒ to the study eye.
3. More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
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 2 years.
5. Presence of other causes of choroidal neovascularixzation, 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.
6. Any intraocular surgery or thermal laser to the study eye within 3 months of trial entry.
7. Any ocular or peri-ocular infection in the past 4 weeks.
8. Previous posterior vitectomy.
9. Previous or concomitant therapy with intravitreous corticosteroids.
10. Previous or concomitant therapy with another investigational agent to treat AMD, except oral supplements of vitamins and minerals.
11. Presence of pigment epithelia tears or rips.
12. Any of the following underlying diseases including:
- Diabetic retinopathy
- History or evidence of severe cardiac disease (e.g. NYHA Functional Class III or IV) clinical or medical history of unstable angina, actute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
- History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- Clinically significant impaired renal (serum creatinine >2.5mg/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 study entry.
13. Previous therapeutic radiation in the region of the study eye.
14. Any treatment with an investigational agent in the past 60 days for any condition.
15. Known serious allergies to the fluorescein dye used in angiography,
contraindications indicated in the product label for Visudyne® / PDT (porphyria), or to the components of Macugen™ formulation.
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