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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.IO

Abstract

PURPOSE

To compare relationships between severity and duration of diabetic macular edema (DME) and visual acuity (VA) observed in the PKC-DRS2 with those from the Early Treatment Diabetic Retinopathy Study (ETDRS) and to assess the effect of the orally administered PKC beta inhibitor ruboxistaurin (RBX) on these parameters.

METHODS

In the PKC-DRS2, patients with moderately severe to very severe nonproliferative diabetic retinopathy (n = 685) were randomly assigned to 32 mg/d RBX or placebo and followed up for 36 months with ETDRS VA measurements and fundus photographs (FP) every 3 to 6 months. Mean VA was calculated across all FP visits for eyes in each level of the ETDRS DME severity scale at those visits. For eyes with baseline VA > or = 20/40, relationships between change in VA from baseline to last visit and duration of severe DME were analyzed with linear regression.

RESULTS

Mean VA decreased by approximately 22 letters between the mildest and most severe levels of the DME scale in the PKC-DRS2, compared with 27 letters in the ETDRS. In the placebo group, the rate of decrease in VA over time associated with duration of severe DME was 0.67 letters per month (24 letters over 36 months, compared with 20 letters over 28-36 months in the ETDRS). This rate was 30% less in the RBX group (0.47 letter per month, P = 0.022).

CONCLUSIONS

The VA decrease in the PKC-DRS2 associated with long-standing DME agrees well with estimates from the ETDRS. RBX appears to ameliorate this decrease, an effect that could be important clinically. (ClinicalTrials.gov number, NCT00604383.).

Authors+Show Affiliations

Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.No affiliation info availableNo 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)

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

Language

eng

PubMed ID

18708615

Citation

Davis, Matthew D., et al. "Effect of Ruboxistaurin On the Visual Acuity Decline Associated With Long-standing Diabetic Macular Edema." Investigative Ophthalmology & Visual Science, vol. 50, no. 1, 2009, pp. 1-4.
Davis MD, Sheetz MJ, Aiello LP, et al. Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Invest Ophthalmol Vis Sci. 2009;50(1):1-4.
Davis, M. D., Sheetz, M. J., Aiello, L. P., Milton, R. C., Danis, R. P., Zhi, X., Girach, A., Jimenez, M. C., & Vignati, L. (2009). Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Investigative Ophthalmology & Visual Science, 50(1), 1-4. https://doi.org/10.1167/iovs.08-2473
Davis MD, et al. Effect of Ruboxistaurin On the Visual Acuity Decline Associated With Long-standing Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2009;50(1):1-4. PubMed PMID: 18708615.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. AU - Davis,Matthew D, AU - Sheetz,Matthew J, AU - Aiello,Lloyd P, AU - Milton,Roy C, AU - Danis,Ronald P, AU - Zhi,Xin, AU - Girach,Aniz, AU - Jimenez,Maria C, AU - Vignati,Louis, AU - ,, Y1 - 2008/08/15/ PY - 2008/8/19/pubmed PY - 2009/1/17/medline PY - 2008/8/19/entrez SP - 1 EP - 4 JF - Investigative ophthalmology & visual science JO - Invest. Ophthalmol. Vis. Sci. VL - 50 IS - 1 N2 - PURPOSE: To compare relationships between severity and duration of diabetic macular edema (DME) and visual acuity (VA) observed in the PKC-DRS2 with those from the Early Treatment Diabetic Retinopathy Study (ETDRS) and to assess the effect of the orally administered PKC beta inhibitor ruboxistaurin (RBX) on these parameters. METHODS: In the PKC-DRS2, patients with moderately severe to very severe nonproliferative diabetic retinopathy (n = 685) were randomly assigned to 32 mg/d RBX or placebo and followed up for 36 months with ETDRS VA measurements and fundus photographs (FP) every 3 to 6 months. Mean VA was calculated across all FP visits for eyes in each level of the ETDRS DME severity scale at those visits. For eyes with baseline VA > or = 20/40, relationships between change in VA from baseline to last visit and duration of severe DME were analyzed with linear regression. RESULTS: Mean VA decreased by approximately 22 letters between the mildest and most severe levels of the DME scale in the PKC-DRS2, compared with 27 letters in the ETDRS. In the placebo group, the rate of decrease in VA over time associated with duration of severe DME was 0.67 letters per month (24 letters over 36 months, compared with 20 letters over 28-36 months in the ETDRS). This rate was 30% less in the RBX group (0.47 letter per month, P = 0.022). CONCLUSIONS: The VA decrease in the PKC-DRS2 associated with long-standing DME agrees well with estimates from the ETDRS. RBX appears to ameliorate this decrease, an effect that could be important clinically. (ClinicalTrials.gov number, NCT00604383.). SN - 1552-5783 UR - https://www.unboundmedicine.com/medline/citation/18708615/Effect_of_ruboxistaurin_on_the_visual_acuity_decline_associated_with_long_standing_diabetic_macular_edema_ L2 - http://iovs.arvojournals.org/article.aspx?doi=10.1167/iovs.08-2473 DB - PRIME DP - Unbound Medicine ER -