Completed

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

What is being tested

ruboxistaurin

+ placebo

Drug

Who is being recruted

Cardiovascular Diseases+6

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: February 2004

See protocol details

Summary

Principal SponsorChromaderm, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleReduction in the Occurrence of Center-Involved Diabetic Macular Edema

NCT00090519

Principal SponsorChromaderm, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

731 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesRetinal DiseasesVascular DiseasesDiabetes Complications

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

32 milligrams (mg) once daily (QD) oral for up to 36 months

Group II

Placebo

QD oral for up to 36 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 84 locations

Suspended

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Woodville, AustraliaOpen For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. in Google Maps

Suspended

Nedlands, Australia

Suspended

Artesia, United States

Suspended

Palm Springs, United States

Completed84 Study Centers