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Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy.
Ophthalmology. 2006 Dec; 113(12):2221-30.O

Abstract

OBJECTIVE

To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes.

DESIGN

Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial.

PARTICIPANTS

Six hundred eighty-five patients randomized at 70 clinical sites.

METHODS

Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye.

MAIN OUTCOME MEASURE

Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy.

RESULTS

Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008).

CONCLUSION

Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy.

Authors+Show Affiliations

Beetham Eye Institute, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA. LPAiello@Joslin.Harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16989901

Citation

PKC-DRS2 Group, et al. "Effect of Ruboxistaurin On Visual Loss in Patients With Diabetic Retinopathy." Ophthalmology, vol. 113, no. 12, 2006, pp. 2221-30.
PKC-DRS2 Group, Aiello LP, Davis MD, et al. Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy. Ophthalmology. 2006;113(12):2221-30.
Aiello, L. P., Davis, M. D., Girach, A., Kles, K. A., Milton, R. C., Sheetz, M. J., Vignati, L., & Zhi, X. E. (2006). Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy. Ophthalmology, 113(12), 2221-30.
PKC-DRS2 Group, et al. Effect of Ruboxistaurin On Visual Loss in Patients With Diabetic Retinopathy. Ophthalmology. 2006;113(12):2221-30. PubMed PMID: 16989901.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ruboxistaurin on visual loss in patients with diabetic retinopathy. AU - ,, AU - Aiello,Lloyd Paul, AU - Davis,Matthew D, AU - Girach,Aniz, AU - Kles,Keri A, AU - Milton,Roy C, AU - Sheetz,Matthew J, AU - Vignati,Louis, AU - Zhi,Xin Eric, Y1 - 2006/09/20/ PY - 2006/05/01/received PY - 2006/07/18/revised PY - 2006/07/19/accepted PY - 2006/9/23/pubmed PY - 2006/12/22/medline PY - 2006/9/23/entrez SP - 2221 EP - 30 JF - Ophthalmology JO - Ophthalmology VL - 113 IS - 12 N2 - OBJECTIVE: To evaluate the effect of ruboxistaurin, an orally administered protein kinase C beta (PKC beta) isozyme-selective inhibitor, on vision loss in patients with diabetes. DESIGN: Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. PARTICIPANTS: Six hundred eighty-five patients randomized at 70 clinical sites. METHODS: Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye. MAIN OUTCOME MEASURE: Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy. RESULTS: Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008). CONCLUSION: Oral ruboxistaurin treatment reduced vision loss, need for laser treatment, and macular edema progression, while increasing occurrence of visual improvement in patients with nonproliferative retinopathy. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/16989901/Effect_of_ruboxistaurin_on_visual_loss_in_patients_with_diabetic_retinopathy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(06)01033-5 DB - PRIME DP - Unbound Medicine ER -