Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy: results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2)

Matthew J Sheetz; Lloyd Paul Aiello; Nazila Shahri; Matthew D Davis; Keri A Kles; Ronald P Danis; Mbdv Study Group

doi:10.1097/IAE.0b013e3181fe545f

Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy: results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2)

Matthew J Sheetz, Lloyd Paul Aiello, Nazila Shahri, Matthew D Davis, Keri A Kles, Ronald P Danis, Mbdv Study Group

Ophthalmology, Department of

27 Citations (Scopus)

Abstract

The PKC-DRS2 was a Phase 3, randomized, double-masked, placebo (PBO)-controlled, 3-year study of the effect of 32 mg/day of ruboxistaurin (RBX), an orally administered protein kinase C inhibitor, on vision loss in patients with moderate to severe nonproliferative diabetic retinopathy. Ruboxistaurin reduced the occurrence of sustained moderate visual loss (SMVL; ≥15-letter decline in visual acuity sustained for the last 6 months of study participation) from 9.1% in the PBO group (N = 340) to 5.5% in the RBX group (N = 345, P = 0.034). This study evaluates the primary end point of SMVL in a 2-year open-label extension (OLE) of the PKC-DRS2, which began a median of 466 days (range, 263-1,296 days) after the conclusion of PKC-DRS2.

Original language	English
Journal	Retina
Volume	31
Issue number	6
Pages (from-to)	1053-9
Number of pages	7
ISSN	0275-004X
DOIs	https://doi.org/10.1097/IAE.0b013e3181fe545f
Publication status	Published - 2011

Keywords

Administration, Oral
Diabetic Retinopathy
Double-Blind Method
Enzyme Inhibitors
Female
Humans
Indoles
Male
Maleimides
Middle Aged
Protein Kinase C
Retreatment
Vision Disorders
Vision Tests
Visual Acuity
Withholding Treatment

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Sheetz, M. J., Aiello, L. P., Shahri, N., Davis, M. D., Kles, K. A., Danis, R. P., & Mbdv Study Group (2011). Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy: results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2). Retina, 31(6), 1053-9. https://doi.org/10.1097/IAE.0b013e3181fe545f

Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy : results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2). / Sheetz, Matthew J; Aiello, Lloyd Paul; Shahri, Nazila et al.

In: Retina, Vol. 31, No. 6, 2011, p. 1053-9.

Research output: Contribution to journal › Journal article › Research › peer-review

Sheetz, MJ, Aiello, LP, Shahri, N, Davis, MD, Kles, KA, Danis, RP & Mbdv Study Group 2011, 'Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy: results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2)', Retina, vol. 31, no. 6, pp. 1053-9. https://doi.org/10.1097/IAE.0b013e3181fe545f

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abstract = "The PKC-DRS2 was a Phase 3, randomized, double-masked, placebo (PBO)-controlled, 3-year study of the effect of 32 mg/day of ruboxistaurin (RBX), an orally administered protein kinase C inhibitor, on vision loss in patients with moderate to severe nonproliferative diabetic retinopathy. Ruboxistaurin reduced the occurrence of sustained moderate visual loss (SMVL; ≥15-letter decline in visual acuity sustained for the last 6 months of study participation) from 9.1% in the PBO group (N = 340) to 5.5% in the RBX group (N = 345, P = 0.034). This study evaluates the primary end point of SMVL in a 2-year open-label extension (OLE) of the PKC-DRS2, which began a median of 466 days (range, 263-1,296 days) after the conclusion of PKC-DRS2.",

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