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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2005-000900-15-ES |
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Date of registration:
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16/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients with Diabetes Mellitus, as assessed by Optical Coherence Tomography
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Scientific title:
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The effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients with Diabetes Mellitus, as assessed by Optical Coherence Tomography |
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Date of first enrolment:
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28/06/2005 |
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Target sample size:
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220 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000900-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Denmark
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Germany
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Lithuania
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Have type 1 or type 2 diabetes mellitus as defined by American Diabetes Association (ADA) and World Health Organization (WHO) criteria.
- Have DME (based on 7-field stereoscopic fundus photogrpahs confirmed by the Fundus Photograph Reading Center) at Visit 1, showing in the study eye:
[A] Any photographically detectable retinal thickening at or between 100 and 500 microns from the center of the macula.
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[B] Retinal thickening >= 1 disc area in size, any part of which is within 1500 microns from the center of the macula,
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[C] Both [A] and [B].
BUT EXCLUDING
Retinal thickening, or hard exudates associated with adjacent retinal thickening, leass than 100 microns from the center of the macula, as noted on stereo fundus photographs.
- Have, in the study eye, a DR level corresponding to ETDRS retinopathy score >=35b and <=53e, as determined by 7-field stereoscopic fundus photographs as confirmed by the Fundus Photograph Reading Center.
- Have, in the study eye, a best-corrected visual acuity of at least 75 letters on the ETDRS visual acuity chart.
- Male or female, aged 18 years or older at Visit 1.
- Have and HbA1c value <=11.0% at Visit 1.
- Have seated BP<= 160/90 mmHg, as determined by the mean of three separate resting measurements at Visit 1. Patients with a BP above this limit may be re-screened 1 month later.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Retinal thickening, or hard exudates associated with adjacent retinal thickening, less than 100 microns from the center of the macula, noted on stereo fundus photographs in the study eye at Visit 1.
- Have had previous photocoagulation for DR and/or DME in the study eye prior to Visit 1.
- Are likely to require focal/grid or pan-retinal (scatter) photocoagulation in the study eye within 3 months of study randomization, in the opinion of the investigator, at Visit 1.
- Have tractional DME, thickened taut posterior hyaloid membrane, or cystoid changes in the study eye, in the opinion of the investigator, as determined by OCT.
- Have had intra-ocular surgery, e.g. cataract extraction, within 6 months of visit 1, and/or anticipated intra-ocular surgery during the study, in the opinion of the investigator, in the study eye.
- Have an occludable anterior chamber angle or open angle glaucoma in the study eye, in the opinion of the investigator, at Visit 1. Ocular hypertension in the absence of a glaucomatous visual field defect is not an exclusion criterion.
- Have current vitreous or pre-retinal hemorrhage in the study eye at Visit 1.
- Have eccentric or imperfect fixation in the study eye at Visit 1.
- Have a history of conditions in the study eye at Visit 1 which, in the opinion of the investigator, might affect macular edema, alter visual acuity, or confound stereoscopic fundus photography or OCT readings, including but not limited to: intra-ocular surgery, significant chorioretinal scars, optic atrophy, retinal degeneration, retinal vein occlusion, retinal artery occlusion, rubeosis iridis, pathologic myopia, age-related macular degeneration, posterior uveitis, branch vein or artery occlusion.
- Are unable to provide adequate OCT readings or fundus photography at Visit 1 ( as assessed by the reading center) for reasons including but not limited to: media opacity or compliance.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetic Macular Edema (DME), is the most common cause of visual impairment in patients with diabetic retinopathy (DR). It is the accumulation of extracellular fluid in the retinal tissues of the macula and is a microvascular complication of diabetes. In this study patients will have macular edema that meets the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant macular edema (CSME), (but patients with imminently vision threatening macular edema are excluded).
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Intervention(s)
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Product Name: Ruboxistaurin
Product Code: LY333531
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ruboxistaurin
CAS Number: 169939-94-0
Current Sponsor code: LY333531
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To test the hypothesis that oral administration of 32 mg per day of ruboxistaurin for approximately 18 months will reduce, relative to placebo, the baseline to endpoint changes in central macular thickness, as measured by OCT, in patients with CSME, but not within 100 microns from the center of the macula at baseline.
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Secondary Objective: Key secondary objective:
- Change in visual acuity from baseline to end of study
Additional secondary objectives:
- Change from baseline to endpoint in mean retinal thickness within 500 microns of the center of the macula, as assessed by OCT.
- Incidence and time to occurrence of significant center-involved macular edema, as assessed by OCT.
- Change from baseline or time to occurrence in any other appropriate measures or treatments of DME or visual function, including but not limited to: photocoagulation, contrast sensitivity, and macular edema volume measures.
- Safety and Tolerability
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Primary end point(s): The primary efficacy measure is the change from baseline to endpoint in absolute retinal thickness at the center of the macula, as determined by OCT.
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Secondary ID(s)
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2005-000900-15-GB
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B7A-MC-MBCU
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/06/2005
Contact:
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