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A Traditional Chinese Patent Medicine ZQMT for Neovascular Age- Related Macular Degeneration: A Multicenter Randomized Clinical Trial

[ Vol. 18 , Issue. 9 ]

Author(s):

M. Jin*, H. Dai, X. Zhang, Y. Wang, M. Han, H. Zhang, Y. Liu, Z. Wang, X. Gao, L. Li, X. Wen, Y. Liu, L. Wei* and Y. Chen*   Pages 622 - 629 ( 8 )

Abstract:


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 complementary 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 an 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 that intravitreal ranibizumab treatment plus ZQMT was non-inferior to the treatment with intravitreal ranibizumab alone in improving visual acuity scores at week 24 with patients in both groups who 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 ease the financial burden of patients undergoing treatment by reducing the frequency of necessary ranibizumab injections.

Keywords:

Age-related macular degeneration, traditional Chinese medicine, clinical trial.

Affiliation:

Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, Department of Ophthalmology, Beijing Hospital, Beijing 100000, Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, Department of Ophthalmology, Beijing Friendship Hospital, Capital Medical University, Beijing 100730, Tianjin Eye Hospital, Tianjin 300020, Department of Ophthalmology, Eye Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100040, Peking University Eye Center, Peking University, Beijing 100191, Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, Chinese Association of Traditional Chinese Medicine, Beijing 100061, Chinese Association of Traditional Chinese Medicine, Beijing 100061, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, Department of Ophthalmology, Peking Union Medical College, Beijing 100730



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