UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001830
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

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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 or person

Institute

NPO HEART

Institute

Department

Personal name



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

Value
https://center6.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