Diabetic Macular Edema (diabetic eye disease)

• Register: EUCTR
• Last refreshed on: 15 May 2012
• Main ID: EUCTR2005-000900-15-DK
• Date of registration: 17/05/2005
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Diabetic Macular Edema (diabetic eye disease)
• Scientific title: The effect of Ruboxistaurin on Vision Loss in Patients with Diabetes Mellitus and Clinically Significant Macular Edema
• Date of first enrolment: 05/07/2005
• Target sample size: 309
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000900-15
• Study type: Interventional clinical trial of medicinal product
• Study design: 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 Number of treatment arms in the trial: 2

Countries of recruitment

Canada, Denmark, Germany, Lithuania, Mexico, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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.
or
[B] Retinal thickening >= 1 disc area in size, any part of which is within 100 microns from the center of the macula,
or
[C] Both [A] and [B].
BUT EXCLUDING
Retinal thickening, or hard exudates associated with adjacent retinal thickening, less 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 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 155

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

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).
MedDRA version: 14.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 10015919 - Eye disorders

Intervention(s)

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

Primary Outcome(s)

Main Objective: To test the hypothesis that oral administration of 32 mg per day of ruboxistaurin will reduce, relative to placebo, the occurrence of SMVL (defined as a 15 letter or more decrease from baseline in best-corrected ETDRS visual acuity in a DR study eye that is sustained for the patient’s last 6 months of study participation).

Primary end point(s): The primary efficacy measure is the occurrence of SMVL. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected ETDRS visual acuity in a DR study eye that is sustained for the patient’s last 6 months of study participation.

Timepoint(s) of evaluation of this end point: 48 months

Secondary Objective: Key secondary objective:
-The SMVL data from this study will be combined with the SMVL data from Study B7A MC MBDL for the purpose of comparing ruboxistaurin to placebo. This endpoint from the two studies combined will be utilized for regulatory submission/response purposes.
Additional secondary objectives:
-Change from baseline to endpoint in retinal thickness at the center of the macula, as measured by OCT, in patients with CSME, not within 100 microns from the center of the macula, at baseline.
- 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

Secondary Outcome(s)

Secondary end point(s): Change from baseline to endpoint in retinal thickness at the center of the macula, as determined by OCT.
Mean retinal thickness, 500 microns in radius from the center of the macula, as assessed using OCT.
Occurrence of significant center-involved macular edema, as assessed by OCT.
For the purposes of this study, significant center-involved macular edema is defined as absolute retinal thickness at the center of the macula > 2 standard deviations (SDs) above the mean baseline value (where the mean and SD are calculated at baseline from the randomized population of patients with retinal thickness values of ? 300 microns in depth).
Occurrence of other measures or treatments of DME or visual function including but not limited to: photocoagulation, contrast sensitivity and macular edema volume measures. Contrast sensitivity will be measured using the Pelli Robson Chart.

Timepoint(s) of evaluation of this end point: 48 months

Secondary ID(s)

B7A-MC-MBCU(b)

2005-000900-15-GB