A Traditional Chinese Patent Medicine ZQMT for Neovascular Age-Related Macular Degeneration: a multicenter randomized clinical trial.

BACKGROUND: Anti-VEGF agent ranibizumab has been extensively used as a standard treatment for wet AMD. We investigated whether traditional Chinese medicine could serve as a complimentary therapy for this disease.

METHODS: 144 patients with neovascular age-related macular degeneration received either intravitreal ranibizumab treatment as needed plus placebo or intravitreal ranibizumab treatment as needed plus a Chinese FDA approved traditional Chinese patent medicine named ZQMT. Both groups received treatment for 24 weeks. The primary outcome was the mean change of visual acuity at week 24 as compared to the baseline.

RESULTS: We found intravitreal ranibizumab treatment plus ZQMT was noninferior to the treatment with intravitreal ranibizumab alone in improving visual acuity scores at Week 24 with patients in both groups gained substantial numbers of letters. In addition, we found that ZQMT treatment resulted in significant improvements in reducing retinal hemorrhage, fluid, and lesion size. Importantly, administration of ZQMT reduced the number of needed ranibizumab injections (P<0.0001, analysis of variance) in wet AMD patients leading to a significant reduction of drug cost.

CONCLUSION: The combinatory therapy of ranibizumab and traditional Chinese patent medicine ZQMT had equivalent effects on visual acuity improvement and safety profiles as the ranibizumab treatment alone. Ranibizumab injections coupled with ZQMT offer therapeutic advantages in terms of reduction of retinal lesions and eases the financial burden of patients undergoing treatment by reducing the frequency of necessary ranibizumab injections.