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OpenTrials
Completed

NCT Number: NCT00133952

Effect of Ruboxistaurin on Clinically Significant Macular Edema

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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., Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 or 2 diabetes
  • 18 years or older
  • Hemoglobin A1c (HbA1c) less than or equal to 11%
  • Mild to very severe non-proliferative diabetic retinopathy in the study eye
  • Clinically significant macular edema in the study eye not within 100 microns of center of macula

Exclusion criteria

  • Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
  • Glaucoma in the study eye
  • Unstable cardiovascular disease
  • Major surgery within past 3 months
  • Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.

Treatment and study plan

ruboxistaurin

Drug

Administered orally

Other names: LY333531

Placebo

Drug

Administered orally

Primary outcomes

  1. Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48

    Time frame: Baseline through 48 months

    SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).

Secondary outcomes

  1. Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula

    Time frame: Baseline, 24 months

    Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  2. Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24

    Time frame: Baseline through 24 months

    Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).

  3. Time to Focal Photocoagulation

    Time frame: Baseline through 48 months

  4. Change From Baseline to Month 24 in Contrast Sensitivity

    Time frame: Baseline, 24 months

    Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  5. Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula

    Time frame: Baseline, up to 24 months

  6. Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

    Time frame: Baseline through 24 months

  7. Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

    Time frame: Baseline through 24 months

  8. Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24

    Time frame: Baseline through 24 months

    Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.

Sponsors and collaborators

Lead sponsor

Chromaderm, Inc.

Industry

Registry information

Official study title

The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2005
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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