Effect of Ruboxistaurin on Clinically Significant Macular Edema

Chromaderm

Status and phase

Completed

Phase 3

Conditions

Diabetic Macular Edema

Treatments

Drug: Ruboxistaurin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00133952

B7A-MC-MBCU (Other Identifier)

5882

Details and patient eligibility

About

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.

Enrollment

309 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.