Effect of Ruboxistaurin on Clinically Significant Macular Edema

C

Chromaderm, Inc.

Status and phase

Completed
Phase 3

Conditions

Diabetic Macular Edema

Treatments

Drug: Ruboxistaurin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00133952
B7A-MC-MBCU (Other Identifier)
5882

Details and patient eligibility

About

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.

Enrollment

309 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

309 participants in 2 patient groups, including a placebo group

Ruboxistaurin
Experimental group
Description:
32 mg taken orally daily for up to 48 months
Treatment:
Drug: Ruboxistaurin
Placebo
Placebo Comparator group
Description:
Taken orally daily for up to 48 months
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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