Effect of Ruboxistaurin on Clinically Significant Macular Edema

Status:	Completed
Conditions:	Cardiology, Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	August 2005
End Date:	July 2011

The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin
will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with
clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from
baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity
that is sustained for the patient's last 6 months of study participation. 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.

Inclusion Criteria:

- Type 1 or 2 diabetes

- 18 years or older

- Hemoglobin A1c (HbA1c) less than or equal to 11%

- Mild to very severe non-proliferative diabetic retinopathy in the study eye

- Clinically significant macular edema in the study eye not within 100 microns of
center of macula

Exclusion Criteria:

- Previous surgery or laser treatment (or need for laser treatment within 3 months) in
the study eye

- Glaucoma in the study eye

- Unstable cardiovascular disease

- Major surgery within past 3 months

- Significantly impaired kidney or liver function, or malignancy requiring chemotherapy
or radiation therapy.

We found this trial at

sites

Clinical Trial Facility in Baltimore Maryland

Baltimore, Maryland

from

Baltimore, MD