Efficacy and safety of maintenance intravitreous injections of pegaptanib sodium every 6 weeks for 48 weeks in subjects with subfoveal neovascular Age-Related Macular Degeneration (AMD) initially treated with a modality resulting in maculopathy improvement: An exploratory study in a clinical setting

UMIN ID: UMIN000001830

Registered date:31/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Age-related macular degeneration
• Date of first enrollment: 2009/04/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The proportion of subjects who remained at baseline or gained vision from baseline to 54 weeks
• Secondary Outcome: *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.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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 –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.

Related Information

• Primary Sponsor: NPO HEART
• Source(s) of Monetary Support: NPO HEART