Abstract
Purpose :
To provide model-based evidence of a relationship between CLS-TA treatment and best corrected visual acuity (BCVA).
Methods :
Data from two Phase 3 trials, PEACHTREE and AZALEA, evaluating suprachoroidal CLS-TA, a proprietary triamcinolone acetonide injectable suspension for the treatment of uveitis, were used to develop model-based treatment-response longitudinal models. These models included disease progression effects from both the control arm (sham procedure with no drug) as well as effects following administration of CLS-TA. A covariate analysis was conducted to identify clinically relevant and statistically significant intrinsic and extrinsic factors affecting changes in BCVA response to CLS-TA treatment. The covariates evaluated included race, age, sex, country, baseline BCVA, baseline central subfield retinal thickness (CST), and anatomic location of ocular inflammation.
Results :
Data from 198 subjects in PEACHTREE and AZALEA were included. Results of the analysis showed that BCVA exhibits CLS-TA treatment-dependent saturable increases over time and CST exhibits CLS-TA treatment-dependent saturable reductions over time. For the BCVA response model, the baseline BCVA score was significantly influenced by three predictors: baseline CST, age, study enrollment criteria (AZALEA study had less strict enrollment critera than the randomized-controlled PEACHTREE trial), while the maximum improvement in BCVA was influenced by the baseline BCVA. Specifically, the maximal increase in BCVA response was significantly influenced by baseline BCVA with greater improvement in subjects with lower baseline BCVA. The typical subject had a baseline BCVA of 56 ETDRS letters read and a baseline CST of 463 microns. The typical improvement was 12 ETDRS letters read and 157 microns decrease in CST following suprachoroidal CLS-TA. In contrast, subjects in the control arm demonstrated an improvement in BCVA of approximately 2 letters and an improvement in CST of approximately 17 microns.
Conclusions :
A model-based treatment-response longitudinal model was developed that characterized changes in both BCVA and CST following administration of CLS-TA. The result of this analysis, based on Phase 3 clinical data, shows that the typical patient will have a 12-letter improvement in BCVA and 157 micron decrease in CST after treatment with CLS-TA.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.