Clinical trial NCT00604383: Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Lead sponsor: Chromaderm, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Hemoglobin A1c (HbA1C) ≤13.0%

Exclusion Criteria:

* 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
* Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control

Primary outcomes:
measure: Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period
timeFrame: Baseline through 36 months
Secondary outcomes:
measure: Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)
timeFrame: Baseline through 36 months
measure: Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)
timeFrame: Baseline through 36 months
measure: Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
timeFrame: Baseline, up to 36 months
measure: Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire
timeFrame: Baseline, up to 36 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: 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.
state: Indiana
Study officials:
affiliation: Chromaderm, Inc.
name: Karl Beutner
role: STUDY_DIRECTOR
References:
citation: 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.