A recent subgroup analysis published in the American Journal of Ophthalmology revealed promising results for a novel topical treatment to improve visual function in patients with early-stage age-related cataracts. The study explored the efficacy of a 2.6% EDTA ophthalmic solution (C-KAD) by specifically focusing on its ability to improve the contrast sensitivity (CS) that deteriorates in the early stages of cataract development.
This multicenter phase 1/2 clinical trial included a total of 41 eyes from subjects who had mesopic contrast sensitivity scores between 1 and 7 grating patches at baseline which indicates mild to moderate loss of CS. These subjects were part of the intent-to-treat population in the original trial. The primary objective of this study was to determine the proportion of eyes showing clinically significant improvements in mesopic CS, defined as an improvement of 0.30 logCS or greater, equivalent to a 100% improvement in CS, at two or more spatial frequencies.
The results of this analysis found 66.7% of the eyes treated with C-KAD to demonstrate significant mesopic CS improvements by Day 120, when compared to only 35.0% in the placebo group (P = .043). This finding not only met the primary endpoint but also highlighted the potential of C-KAD as a noninvasive pharmacological treatment for early-stage cataract patients.
Further analysis showed that the proportion of eyes achieving significant improvements in the area under the log contrast sensitivity function (AULCSF) was also significantly higher in the C-KAD group (42.9%) when compared to the placebo group (15.0%, P = .050). The mean change in AULCSF was markedly larger in the C-KAD group, with an average improvement of 0.25 logCS versus just 0.06 logCS in the placebo group (P = .020). Also, C-KAD showed significant improvements in mesopic CS at specific spatial frequencies, particularly at 3 cycles per degree (cpd) and 6 cpd. The mean CS improvements at these frequencies were 0.28 logCS (P = .004) and 0.31 logCS (P = .047), respectively by further highlighting the efficacy of the treatment.
Exploratory outcomes, such as best-corrected visual acuity (BCVA) and lens density changes, were also examined in a smaller subset of eyes. Positive trends in BCVA and statistically significant reductions in lens density were observed in the C-KAD group which suggests additional benefits beyond CS improvement. Overall, the study unveiled that C-KAD offers a significant improvement in visual function and quality of vision for patients with early-stage cataracts.
Source:
KUBOI, T., CHUCK, R. S., PINEDA, R., II, BHUSHAN, R., GOSWAMY, A., & OLSON, R. J. (2024). Subgroup Analysis from a Phase 1/2 Randomized Clinical Trial of 2.6% EDTA Ophthalmic Solution in Patients with Age-Related Cataract. In American Journal of Ophthalmology (Vol. 268, pp. 155–164). Elsevier BV. https://doi.org/10.1016/j.ajo.2024.07.038