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

Department of Ophthalmology

33 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

Access to Document

10.1097/IAE.0b013e3181fe545f

Fingerprint

Dive into the research topics of '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)'. Together they form a unique fingerprint.

Cite this

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

@article{2fb9ca7cb7e04be6bb27e4ead99d056b,

title = "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)",

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.",

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",

author = "Sheetz, \{Matthew J\} and Aiello, \{Lloyd Paul\} and Nazila Shahri and Davis, \{Matthew D\} and Kles, \{Keri A\} and Danis, \{Ronald P\} and \{Mbdv Study Group\}",

year = "2011",

doi = "10.1097/IAE.0b013e3181fe545f",

language = "English",

volume = "31",

pages = "1053--9",

journal = "Retina",

issn = "0275-004X",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

TY - JOUR

T1 - Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy

T2 - results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2)

AU - Sheetz, Matthew J

AU - Aiello, Lloyd Paul

AU - Shahri, Nazila

AU - Davis, Matthew D

AU - Kles, Keri A

AU - Danis, Ronald P

AU - Mbdv Study Group

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Diabetic Retinopathy

KW - Double-Blind Method

KW - Enzyme Inhibitors

KW - Female

KW - Humans

KW - Indoles

KW - Male

KW - Maleimides

KW - Middle Aged

KW - Protein Kinase C

KW - Retreatment

KW - Vision Disorders

KW - Vision Tests

KW - Visual Acuity

KW - Withholding Treatment

UR - https://www.scopus.com/pages/publications/79958295090

U2 - 10.1097/IAE.0b013e3181fe545f

DO - 10.1097/IAE.0b013e3181fe545f

M3 - Journal article

C2 - 21386766

SN - 0275-004X

VL - 31

SP - 1053

EP - 1059

JO - Retina

JF - Retina

IS - 6

ER -

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)

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this