Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
NCT ID: NCT00604383
Last Updated: 2016-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
685 participants
INTERVENTIONAL
2001-03-31
2005-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
NCT03238963
A Study Assessing Efficacy and Safety of OC-10X in the Treatment of PDR
NCT02735369
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
NCT06990269
A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07029945
Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease
NCT03033108
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ruboxistaurin
ruboxistaurin
32-mg tablet, orally, daily, up to 42 months
Placebo
placebo
1 tablet, orally, daily, up to 42 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ruboxistaurin
32-mg tablet, orally, daily, up to 42 months
placebo
1 tablet, orally, daily, up to 42 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Hemoglobin A1c (HbA1C) ≤13.0%
Exclusion Criteria
* 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
* Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chromaderm, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl Beutner
Role: STUDY_DIRECTOR
Chromaderm, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Davis MD, Sheetz MJ, Aiello LP, Milton RC, Danis RP, Zhi X, Girach A, Jimenez MC, Vignati L; PKC-DRS2 Study Group. Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):1-4. doi: 10.1167/iovs.08-2473. Epub 2008 Aug 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B7A-MC-MBCM
Identifier Type: OTHER
Identifier Source: secondary_id
4743
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.