Unique ID issued by UMIN | UMIN000001830 |
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Receipt number | R000002168 |
Scientific Title | 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 |
Date of disclosure of the study information | 2009/03/31 |
Last modified on | 2012/04/02 08:37:35 |
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
Assessing efficacy and safety of maintenance therapy with pegaptanib sodium: LEVEL-J Study
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
Assessing efficacy and safety of maintenance therapy with pegaptanib sodium: LEVEL-J Study
Japan |
Age-related macular degeneration
Ophthalmology |
Others
NO
To explore the 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
Safety,Efficacy
Exploratory
Not applicable
The proportion of subjects who remained at baseline or gained vision from baseline to 54 weeks
*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.
Observational
50 | years-old | <= |
Not applicable |
Male and Female
*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
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.
150
1st name | |
Middle name | |
Last name | Ishibasi Tatsuro |
Graduate School of Medical Sciences,Kyusyu University
Department of Ophthalmology
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-641-1151
1st name | |
Middle name | |
Last name | Inano Akihiro |
NPO HEART
Hokuriku Clinical Trial Supporting Center
076-265-7570
http://www.kanazawa-univ-pharm.jp/levelj/index.html
inano-heart@bpost.plala.or.jp
NPO HEART
NPO HEART
Self funding
NO
2009 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2009 | Year | 01 | Month | 28 | Day |
2009 | Year | 04 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
To explore the 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
2009 | Year | 03 | Month | 31 | Day |
2012 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002168
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