Macular Drusen Size in a Phase 2 Clinical Trial Evaluating Resveratrol, Quercetin, and Curcumin (RQC)

Abstract

Purpose : Dry age-related macular degeneration (AMD) is a retinal degenerative disease without known treatment. The early to intermediate form of the disease is characterized by the accumulation of extracellular material into deposits called drusen under the retinal pigment epithelium. Large drusen are a significant risk factor for progression to the advanced dry or wet forms of the disease. In this study, we evaluated the effect of resveratrol, quercetin, and curcumin in combination (RQC) on drusen volume over one year in patients with intermediate AMD.

Methods : All participants were recruited from the office of Zaparackas & Knepper Ltd. in Chicago, Illinois and randomized into groups taking either oral RQC or curcumin alone. Included participants had completed one year of follow-up at the time of analysis (n=25). Drusen volume in mm³ was measured manually in each subject using OCT images taken serially at baseline, 3 months, 6 months, and 1 year. The change in drusen volume from baseline was compared between the RQC and curcumin groups and with the expected change based on a meta-analysis of drusen volume natural history studies by Wang et al. (2021).

Results : In the RQC group, mean drusen volume decreased 10.0% from 0.120 (SD 0.084) to 0.108 (0.073) mm³ after one year. In the curcumin group, mean drusen volume decreased 3.7% from 0.091 (0.070) to 0.087 (0.067) mm³ after one year. Compared directly, drusen volume decreased significantly more in participants taking RQC (p=0.008). The expected change in untreated subjects was about +7% after one year, which was significantly greater than the -10.0% change observed in the RQC group (p<0.0001).

Conclusions : Phase 2 advanced dry AMD patients taking RQC had significantly decreased drusen volume after one year compared with participants taking curcumin alone and with untreated patients. These results support previous phase 1 studies and suggest that RQC may reduce the risk of progression to advanced AMD in patients with drusen.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

Fig. 1 shows the expected change in drusen volume in untreated subjects based on an independent meta-analysis (dashed line) compared with the change in subjects taking curcumin alone (solid line, triangles) and RQC (solid line, circles).