Age-related macular degeneration
Conditions
Interventions
None listed
Sponsors
NPO HEART
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Subfoveal CNV secondary to AMD *Following prior treatments for AMD which have occurred between 30 and 120 days prior to entry in the study: 1. at least 1, but not more than 3 ranibizumab, 2. at least 1, but not more than 2 PDT; 3. At least 1, but not than 3 pegaptanib; or combination of 1, 2 or 3 treatments. Combination of different therapies may be used and each combination counts as 1 treatment. *Improvement of exudative maculopathy following previous AMD treatment based upon clinical and/or anatomical findings determined by the investigator *OCT retinal thickness at center point of 150-300 microns at study entry *Best corrected visual acuity in the study eyes of <=1.3 in a LogMar chart, >=20 ETDRS letters, or >= 20/400 in a Snellen chart *Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be <=12 Disc Areas *Written informed consent *Ability to return for all study visits
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for the study if subjects cannot attend all study required visits, or if any of the following criteria are present systemically or in the study eye: 1. 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. 2. Significant media opacities, including cataract, which might interfere with visual acuity. Subjects should not be entered if there is likelihood that they will require cataract surgery in either eye within the following 2 years. 3. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of &#8211;8 diopters or more negative, or axial length of 26.5mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis. 4. Any intraocular surgery to the study eye within 3 months of study entry. Previous history of filtering surgery (e.g. trabeculectomy) or the placement of a glaucoma drainage device. 5. Any ocular or periocular infection in the past 4 weeks. 6. Previous posterior vitrectomy. 7. Presence of pigment epithelial tears or rips. 8. Any 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 16.6), 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. * History or evidence of clinically significant impaired renal or hepatic function * Stroke (within 12 months of study entry). * Any major surgical procedure within one month of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who remained at baseline or gained vision from baseline to 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| *The proportion of subjects who remained at baseline or gained vision from baseline to 24 weeks. *The proportion of subjects who remained at baseline or gained vision from baseline to the end of treatment (or early withdrawal). *Proportion of subjects maintaining or gaining 1, 2 and 3 lines of visual acuity at week 54 compared to pre-enrollment (treatment initiation baseline) baseline vision. *Mean change of visual acuity from baseline to Week 54. *Proportion of subjects losing less than 3 lines of vision at 54 weeks. *Anatomical outcomes on OCT and FFA. | — |
Countries
Japan
Contacts
Public ContactInano Akihiro
NPO HEART Hokuriku Clinical Trial Supporting Center
Outcome results
None listed