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Retina Associates - Research Coordinators
 
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Study Detail: Lilly MBCU

Trial Description

Summary : A study to evaluate the safety and effectiveness of the use of an oral experimental drug (Ruboxistaurin) in the reduction of central retinal thickening - macular edema (swelling) found in diabetics with diabetic eye disease. Measurements of retinal thickness will be done by OCT-Optical Coherent Tomography which is a non-invasive scan of the retina. Patients will be randomized (chosen like a flip of a coin) to take either 32 mg of Ruboxistaurin or a placebo (fake pill) once daily.

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

2b

Diabetic Retinopathy

Recruiting

18 year or older

Eli Lilly and Company

B7A-MC-MBCU

Study Duration: Six (6) visits over 18 months.

 

Eligibility Criteria:

Inclusion Criteria

· DME (based on 7-field stereos confirmed by Reading Center) from Visit 1 showing:

1. Any photographically detectable retinal thickening at or between 100 and 500 microns from center of macula

2. Retinal Thickening ≥ 1 disc area in size, any part of which is within 1500 microns from center macula

3. Or both of the above

*But not: Retinal Thickening or hard exudates associated with adjacent retinal thickening, less than 100 microns from center macula, found on stereo photos

· ETDRS retinopathy scores ≥ 35b and ≤ 53e confirmed by Reading Center

· Best-corrected VA 75 Letters ETDRS (20/32)

· HbA1c ≤ 11.0% at Visit 1

· BP ≤ 160/90 mmHg, determined by 3resting measurements at Visit 1

Please speak with the clincial coordinator about other inclusion criteria

 

Exclusion Criteria

· Retinal Thickening or hard exudates associated with adjacent retinal thickening, less than 100 microns from center macula, found on stereo photos

· Prior laser for DR and/or DME in study eye prior to Visit 1

· Are likely to have focal and/or scattered laser in study within 3 months of randomization

· Tractional DME, thickened taut posterior hyaloid membrane, or cystoid changes in study eye determined by OCT.

· Intra-Ocular surgery within 6 months of Visit 1 or anticipated during study.

· Have occludable anterior chamber angle or open angle glaucoma in opinion of investigator at Visit 1

· Current Vitreous or pre-retinal hemorrhage in study eye

· History of condition in study eye at Visit 1 which might affect macular edema, alter VA, or confound Stereo Fundus or OCT readings in the investigators opinion.

· Unstable cardiovascular disease

· Have had major abdominal, thoracic, vascular, or cranial surgery within 3 months prior to Visit 1

· Have malignancy (other than basal cell) at Visit 1 and are currently on radiation/chemotherapy or plan to receive in next 18 months

· CS impaired renal function, defined by serum creatinine greater than 4.0mg/dL at Visit 1

· Like to require treatment for more than 2 weeks with protein inhibitors or cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) during study

Please speak with the clinical coordinator about other exclusion criteria

 

Study Title : The Effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients with Diabetes Mellitus, assessed by Optical Coherence Tomography

 

Trial Contact Information

Site

Study Coordinator

Beachwood

Diane W 216-831-5704 Ext 6800

Lakewood

Susan 216-831-5704 Ext 6800