Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy
PurposeTo compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).DesignMulticenter, randomized, non-inferiority clinical trial.SubjectsNaïve PCV patients.MethodsPatients were ra...
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Frontiers Media S.A.
2022-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2021.791935/full |
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| author | Zuhua Sun Yuanyuan Gong Yating Yang Ying Huang Suqin Yu Junqing Pei Bing Lin Rong Zhou Yingzi Li Yumin Li Junyan Zhang Xiaoling Liu |
| author_facet | Zuhua Sun Yuanyuan Gong Yating Yang Ying Huang Suqin Yu Junqing Pei Bing Lin Rong Zhou Yingzi Li Yumin Li Junyan Zhang Xiaoling Liu |
| author_sort | Zuhua Sun |
| collection | DOAJ |
| description | PurposeTo compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).DesignMulticenter, randomized, non-inferiority clinical trial.SubjectsNaïve PCV patients.MethodsPatients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. At baseline, patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group.Main Outcome MeasuresNon-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above −5 letters).ResultsEighty-six patients were enrolled, with 43 in each group. At month 12, the change of BCVA in initial combination group was equivalent to that in the delayed combination group, with gains of 6.42 ± 1.89 and 7.49 ± 2.14 (mean ± standard error) letters, respectively [delayed group minus initial group: 1.07 letters; 95% confidence interval (CI): −4.62 to 6.76; Pnon−inferiority = 0.0198]. The rates of complete polyp regression were 66.67 and 45.83% in the initial and delayed combination groups, respectively. The difference was not statistically significant (P = 0.386). The mean reductions of CRT were 204.77 ± 28.79 and 84.14 ± 30.62 μm in each group respectively. The difference was statistically significant (P = 0.005). In addition, the mean injection numbers were 3.47 ± 2.39 and 4.91 ± 2.65 in each group respectively. The differences were statistically significant (P = 0.010).ConclusionsThere was effective in both groups in patients with PCV. The initial combination group showed a more efficient decrease in CRT and polyp regression, along with fewer injections. However, the delayed combination group was non-inferior compared with the initial combination group in terms of the improvement of BCVA.Trial Registrationhttps://ClinicalTrials.gov, Identifier: NCT02821520. |
| first_indexed | 2024-12-12T15:20:06Z |
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| institution | Directory Open Access Journal |
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| last_indexed | 2024-12-12T15:20:06Z |
| publishDate | 2022-02-01 |
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| series | Frontiers in Medicine |
| spelling | doaj.art-28ebfcc6a2dd4676a89aeaba8d1577532022-12-22T00:20:24ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-02-01810.3389/fmed.2021.791935791935Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal VasculopathyZuhua Sun0Yuanyuan Gong1Yating Yang2Ying Huang3Suqin Yu4Junqing Pei5Bing Lin6Rong Zhou7Yingzi Li8Yumin Li9Junyan Zhang10Xiaoling Liu11School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaDepartment of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaDepartment of Ophthalmology, Sir Run Run Shaw Hospital, Medical College of Zhejiang University, Hangzhou, ChinaBothwin Clinical Study Consultant, Shanghai, ChinaSchool of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, ChinaPurposeTo compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).DesignMulticenter, randomized, non-inferiority clinical trial.SubjectsNaïve PCV patients.MethodsPatients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. At baseline, patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group.Main Outcome MeasuresNon-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above −5 letters).ResultsEighty-six patients were enrolled, with 43 in each group. At month 12, the change of BCVA in initial combination group was equivalent to that in the delayed combination group, with gains of 6.42 ± 1.89 and 7.49 ± 2.14 (mean ± standard error) letters, respectively [delayed group minus initial group: 1.07 letters; 95% confidence interval (CI): −4.62 to 6.76; Pnon−inferiority = 0.0198]. The rates of complete polyp regression were 66.67 and 45.83% in the initial and delayed combination groups, respectively. The difference was not statistically significant (P = 0.386). The mean reductions of CRT were 204.77 ± 28.79 and 84.14 ± 30.62 μm in each group respectively. The difference was statistically significant (P = 0.005). In addition, the mean injection numbers were 3.47 ± 2.39 and 4.91 ± 2.65 in each group respectively. The differences were statistically significant (P = 0.010).ConclusionsThere was effective in both groups in patients with PCV. The initial combination group showed a more efficient decrease in CRT and polyp regression, along with fewer injections. However, the delayed combination group was non-inferior compared with the initial combination group in terms of the improvement of BCVA.Trial Registrationhttps://ClinicalTrials.gov, Identifier: NCT02821520.https://www.frontiersin.org/articles/10.3389/fmed.2021.791935/fullpolypoidal choroidal vasculopathyphotodynamic therapyconberceptnon-inferiorityefficacy |
| spellingShingle | Zuhua Sun Yuanyuan Gong Yating Yang Ying Huang Suqin Yu Junqing Pei Bing Lin Rong Zhou Yingzi Li Yumin Li Junyan Zhang Xiaoling Liu Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy Frontiers in Medicine polypoidal choroidal vasculopathy photodynamic therapy conbercept non-inferiority efficacy |
| title | Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy |
| title_full | Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy |
| title_fullStr | Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy |
| title_full_unstemmed | Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy |
| title_short | Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy |
| title_sort | efficacy of initial vs delayed photodynamic therapy in combination with conbercept for polypoidal choroidal vasculopathy |
| topic | polypoidal choroidal vasculopathy photodynamic therapy conbercept non-inferiority efficacy |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2021.791935/full |
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