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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001830
Receipt No. 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

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Basic information
Public 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
Acronym Assessing efficacy and safety of maintenance therapy with pegaptanib sodium: LEVEL-J Study
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
Scientific Title:Acronym Assessing efficacy and safety of maintenance therapy with pegaptanib sodium: LEVEL-J Study
Region
Japan

Condition
Condition Age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of subjects who remained at baseline or gained vision from baseline to 54 weeks
Key secondary outcomes *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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishibasi Tatsuro
Organization Graduate School of Medical Sciences,Kyusyu University
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Inano Akihiro
Organization NPO HEART
Division name Hokuriku Clinical Trial Supporting Center
Zip code
Address
TEL 076-265-7570
Homepage URL http://www.kanazawa-univ-pharm.jp/levelj/index.html
Email inano-heart@bpost.plala.or.jp

Sponsor
Institute NPO HEART
Institute
Department

Funding Source
Organization NPO HEART
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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

Management information
Registered date
2009 Year 03 Month 31 Day
Last modified on
2012 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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