Phase 3 N=731 Randomized Quadruple-blind Treatment

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Diabetic Retinopathy

Bottom Line

View on ClinicalTrials.gov: NCT00090519 ↗

Enrolled (actual)

731

Serious AEs

23.9%

Results posted

May 2016

Primary outcome: Primary: Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) — 1.72; 1.69 months per participant — p=0.969

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ruboxistaurin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chromaderm, Inc.
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)	1.72; 1.69	0.969
PRIMARY Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye	8; 16; 334; 315	0.081
SECONDARY Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months	84.12; 84.27; -1.14; -2.30	0.015 sig
SECONDARY First Occurrence of Focal/Grid Photocoagulation	32; 27; 339; 333	0.577
SECONDARY Change From Baseline in Contrast Sensitivity by Pelli-Robson	33.54; 33.71; -0.54; -1.06	0.041 sig
SECONDARY Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography	328; 312; 43; 48	0.475
SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate	85.35; 87.27; -5.55; -7.92	0.211
SECONDARY Change From Baseline at Endpoint in Albumin/Creatinine Ratio	123.53; 152.61; 135.90; 72.69	0.365
SECONDARY Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months	67.86; 67.56; 0.17; -1.36	0.009 sig
SECONDARY Number of Participants With Adverse Events	93; 82; 298; 299	—

Summary

The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

Eligibility Criteria

Inclusion Criteria

Type 1 or Type 2 diabetes
18 years or older
Non-clinically significant diabetic macular edema
Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
Relatively good vision (20/30 or better)

Exclusion Criteria

Surgery or laser treatment in the study eye
Glaucoma in the study eye
Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
Liver disease, dialysis or renal transplant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.