Tags

Type your tag names separated by a space and hit enter

Effect of ruboxistaurin on blood-retinal barrier permeability in relation to severity of leakage in diabetic macular edema.
Invest Ophthalmol Vis Sci. 2005 Oct; 46(10):3855-8.IO

Abstract

PURPOSE

The purpose of the study was to investigate the effect of orally administered ruboxistaurin (RBX, LY333531), a selective protein kinase C beta inhibitor, on the permeability of the blood-retinal barrier in patients with diabetic macular edema.

METHODS

Forty-one patients with diabetic macular edema were randomly assigned to an 18-month randomized, placebo-controlled, double-masked trial including four study arms (4, 16, or 32 mg/d RBX, or placebo). The RBX group comprised 30 patients (42 eyes) and the placebo group 11 patients (13 eyes). Retinal vascular leakage was assessed using vitreous fluorometry at baseline and after 3, 12, and 18 months. Statistical analysis of the effect of treatment accounted for repeated measurements and tested potential interaction with baseline permeability, HbA(1c), and arterial blood pressure.

RESULTS

Statistical analysis and modeling demonstrated a significant interaction between RBX treatment at any dosage and baseline permeability (P = 0.032, mixed models). A threefold or higher increase in retinal vascular leakage at baseline was associated with a significant reduction (30%) in retinal vascular leakage after RBX treatment compared with placebo. Visual acuity was normal at baseline and remained unchanged throughout the study.

CONCLUSIONS

RBX treatment was associated with a reduction of retinal vascular leakage in eyes that had diabetic macular edema and markedly elevated leakage at baseline. These data suggest that clinical benefit from RBX treatment may be most prominent in patients with severe macular edema at baseline, and trials investigating this therapy may benefit from stratification according to baseline leakage.

Authors+Show Affiliations

Department of Ophthalmology, Herlev Hospital, University of Copenhagen, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16186374

Citation

Strøm, Charlotte, et al. "Effect of Ruboxistaurin On Blood-retinal Barrier Permeability in Relation to Severity of Leakage in Diabetic Macular Edema." Investigative Ophthalmology & Visual Science, vol. 46, no. 10, 2005, pp. 3855-8.
Strøm C, Sander B, Klemp K, et al. Effect of ruboxistaurin on blood-retinal barrier permeability in relation to severity of leakage in diabetic macular edema. Invest Ophthalmol Vis Sci. 2005;46(10):3855-8.
Strøm, C., Sander, B., Klemp, K., Aiello, L. P., Lund-Andersen, H., & Larsen, M. (2005). Effect of ruboxistaurin on blood-retinal barrier permeability in relation to severity of leakage in diabetic macular edema. Investigative Ophthalmology & Visual Science, 46(10), 3855-8.
Strøm C, et al. Effect of Ruboxistaurin On Blood-retinal Barrier Permeability in Relation to Severity of Leakage in Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2005;46(10):3855-8. PubMed PMID: 16186374.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ruboxistaurin on blood-retinal barrier permeability in relation to severity of leakage in diabetic macular edema. AU - Strøm,Charlotte, AU - Sander,Birgit, AU - Klemp,Kristian, AU - Aiello,Lloyd Paul, AU - Lund-Andersen,Henrik, AU - Larsen,Michael, PY - 2005/9/28/pubmed PY - 2005/12/13/medline PY - 2005/9/28/entrez SP - 3855 EP - 8 JF - Investigative ophthalmology & visual science JO - Invest. Ophthalmol. Vis. Sci. VL - 46 IS - 10 N2 - PURPOSE: The purpose of the study was to investigate the effect of orally administered ruboxistaurin (RBX, LY333531), a selective protein kinase C beta inhibitor, on the permeability of the blood-retinal barrier in patients with diabetic macular edema. METHODS: Forty-one patients with diabetic macular edema were randomly assigned to an 18-month randomized, placebo-controlled, double-masked trial including four study arms (4, 16, or 32 mg/d RBX, or placebo). The RBX group comprised 30 patients (42 eyes) and the placebo group 11 patients (13 eyes). Retinal vascular leakage was assessed using vitreous fluorometry at baseline and after 3, 12, and 18 months. Statistical analysis of the effect of treatment accounted for repeated measurements and tested potential interaction with baseline permeability, HbA(1c), and arterial blood pressure. RESULTS: Statistical analysis and modeling demonstrated a significant interaction between RBX treatment at any dosage and baseline permeability (P = 0.032, mixed models). A threefold or higher increase in retinal vascular leakage at baseline was associated with a significant reduction (30%) in retinal vascular leakage after RBX treatment compared with placebo. Visual acuity was normal at baseline and remained unchanged throughout the study. CONCLUSIONS: RBX treatment was associated with a reduction of retinal vascular leakage in eyes that had diabetic macular edema and markedly elevated leakage at baseline. These data suggest that clinical benefit from RBX treatment may be most prominent in patients with severe macular edema at baseline, and trials investigating this therapy may benefit from stratification according to baseline leakage. SN - 0146-0404 UR - https://www.unboundmedicine.com/medline/citation/16186374/Effect_of_ruboxistaurin_on_blood_retinal_barrier_permeability_in_relation_to_severity_of_leakage_in_diabetic_macular_edema_ L2 - http://iovs.arvojournals.org/article.aspx?doi=10.1167/iovs.05-0096 DB - PRIME DP - Unbound Medicine ER -