Tags

Type your tag names separated by a space and hit enter

Sustained moderate visual loss as a predictive end point for visual loss in non-proliferative diabetic retinopathy.
Eye (Lond). 2009 Jan; 23(1):209-14.E

Abstract

PURPOSE

In PKC-DRS2, the efficacy of the oral PKC-beta inhibitor, ruboxistaurin 32 mg/day, was measured by the primary end point of sustained moderate visual loss (SMVL: a > or = 15 letter decrease from baseline on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart sustained at least for the last 6 months of study participation). We now evaluate whether SMVL is more accurate than moderate visual loss (MVL: a single occurrence of a decrease from baseline of > or = 15 ETDRS letters) for predicting future visual loss.

METHODS

Study eyes with moderately severe to very-severe non-proliferative diabetic retinopathy, best-corrected visual acuity of at least 45 letters on the ETDRS chart (approximately Snellen 20/125), and no prior pan retinal photocoagulation were evaluated in 506 patients (869 eyes) who completed 36 months of treatment.

RESULTS

Sixty-five percentage (26/40) of study eyes with the onset of SMVL within 24 months of enrolment still had SMVL at study completion (36 months). In comparison, only 24% (30/126) with MVL within 24 months had SMVL at study completion. Analyses based on data from 6, 12, and 18 months of treatment were similar.

CONCLUSIONS

SMVL is a more predictable measure of subsequent visual loss than is a single time point measure of MVL.

Authors+Show Affiliations

Department of Ophthalmology, Merck Research Laboratories, Hertfordshire, UK. aniz_girach@merck.comNo 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)

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

Language

eng

PubMed ID

18989348

Citation

Girach, A, et al. "Sustained Moderate Visual Loss as a Predictive End Point for Visual Loss in Non-proliferative Diabetic Retinopathy." Eye (London, England), vol. 23, no. 1, 2009, pp. 209-14.
Girach A, Aiello LP, Milton RC, et al. Sustained moderate visual loss as a predictive end point for visual loss in non-proliferative diabetic retinopathy. Eye (Lond). 2009;23(1):209-14.
Girach, A., Aiello, L. P., Milton, R. C., Davis, M. D., Danis, R. P., Zhi, X., Sheetz, M. J., & Vignati, L. (2009). Sustained moderate visual loss as a predictive end point for visual loss in non-proliferative diabetic retinopathy. Eye (London, England), 23(1), 209-14. https://doi.org/10.1038/eye.2008.324
Girach A, et al. Sustained Moderate Visual Loss as a Predictive End Point for Visual Loss in Non-proliferative Diabetic Retinopathy. Eye (Lond). 2009;23(1):209-14. PubMed PMID: 18989348.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sustained moderate visual loss as a predictive end point for visual loss in non-proliferative diabetic retinopathy. AU - Girach,A, AU - Aiello,L P, AU - Milton,R C, AU - Davis,M D, AU - Danis,R P, AU - Zhi,X, AU - Sheetz,M J, AU - Vignati,L, AU - ,, Y1 - 2008/11/07/ PY - 2008/11/8/pubmed PY - 2009/7/23/medline PY - 2008/11/8/entrez SP - 209 EP - 14 JF - Eye (London, England) JO - Eye (Lond) VL - 23 IS - 1 N2 - PURPOSE: In PKC-DRS2, the efficacy of the oral PKC-beta inhibitor, ruboxistaurin 32 mg/day, was measured by the primary end point of sustained moderate visual loss (SMVL: a > or = 15 letter decrease from baseline on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart sustained at least for the last 6 months of study participation). We now evaluate whether SMVL is more accurate than moderate visual loss (MVL: a single occurrence of a decrease from baseline of > or = 15 ETDRS letters) for predicting future visual loss. METHODS: Study eyes with moderately severe to very-severe non-proliferative diabetic retinopathy, best-corrected visual acuity of at least 45 letters on the ETDRS chart (approximately Snellen 20/125), and no prior pan retinal photocoagulation were evaluated in 506 patients (869 eyes) who completed 36 months of treatment. RESULTS: Sixty-five percentage (26/40) of study eyes with the onset of SMVL within 24 months of enrolment still had SMVL at study completion (36 months). In comparison, only 24% (30/126) with MVL within 24 months had SMVL at study completion. Analyses based on data from 6, 12, and 18 months of treatment were similar. CONCLUSIONS: SMVL is a more predictable measure of subsequent visual loss than is a single time point measure of MVL. SN - 1476-5454 UR - https://www.unboundmedicine.com/medline/citation/18989348/Sustained_moderate_visual_loss_as_a_predictive_end_point_for_visual_loss_in_non_proliferative_diabetic_retinopathy_ L2 - http://dx.doi.org/10.1038/eye.2008.324 DB - PRIME DP - Unbound Medicine ER -