Completed

Phase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ruboxistaurin

+ placebo

Drug
Who is being recruted

Cardiovascular Diseases+6

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2001
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: March 1, 2001

Actual date on which the first participant was enrolled.

This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.

Official TitlePhase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.
NCT00604383
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

685 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 mellitus
18 years or older
Meet specific requirements for diabetic retinopathy
Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
Show More Criteria
5 exclusion criteria prevent from participating
History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
Investigators, site personnel directly affiliated with the study and their families
Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
Presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study
Show More Criteria

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

Group II

Placebo

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 1 location

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.

Indianapolis, United StatesOpen 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
CompletedOne Study Center