Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study
AIM: To evaluate the efficacy and safety of concurrent intravitreal ranibizumab (IVR) and extended-release dexamethasone injections (Dex-I) in naïve and refractory patients with retinal vein occlusion macular edema (RVO-ME). METHODS: This was a prospective, interventional, and open-label clinical tr...
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Press of International Journal of Ophthalmology (IJO PRESS)
2025-05-01
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| author | Yao-Yao Sun Jie Meng Shan-Shan Li Qin Xiao Tian-Zi Zhang Heng Miao Ming-Wei Zhao Hui-Jun Qi |
| author_facet | Yao-Yao Sun Jie Meng Shan-Shan Li Qin Xiao Tian-Zi Zhang Heng Miao Ming-Wei Zhao Hui-Jun Qi |
| author_sort | Yao-Yao Sun |
| collection | DOAJ |
| description | AIM: To evaluate the efficacy and safety of concurrent intravitreal ranibizumab (IVR) and extended-release dexamethasone injections (Dex-I) in naïve and refractory patients with retinal vein occlusion macular edema (RVO-ME). METHODS: This was a prospective, interventional, and open-label clinical trial. There were two groups: naïve and refractory patients (received ≥5 times of previous IVR within one year prior to enrollment) enrolled. Patients received IVR and Dex-I concurrently and re-combination therapy was required if one or more retreatment criteria were met. IVR and Dex-I were given pro re nata (PRN). The mean changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured as main outcomes. RESULTS: Totally 63 patients (63 eyes) completed the entire follow-up (31 naïve and 32 refractory patients). At month 12, the change in BCVA was greater in the naïve group than in the refractory group [19.67±11.7 (95%CI: 15.03, 24.31) letters vs 11.74±11.18 (95%CI: 7.32, 16.16) letters, P=0.014). There was no difference between the two groups of mean macular thickness reduction [364.26±215.29 (95%CI: 279.09, 449.43) μm vs 410.19±204.34 (95%CI: 329.35, 491.02) μm, P=0.43). The mean co-injection numbers were 2.52±0.58 (95%CI: 2.29, 2.75) and 2.33±0.55 (95%CI: 2.11, 2.55) in both groups (P=0.24), respectively. The retreatment interval was 115.81±13.79 d (95%CI: 110.36, 121.27) and 122.74±14.06 d (95%CI: 119.93, 133.56) in both groups (P=0.073). There was no significant difference in the incidence of glaucoma or the progression of cataracts between the two groups. CONCLUSION: In both naïve and refractory RVO-ME patients, IVR combined with Dex-I is effective. The initial combination therapy for naïve patients demonstrates more efficient improvement in BCVA and may reduce total injection numbers compared to refractory patients. |
| format | Article |
| id | doaj-art-e48619b00a194de79daacfeeee0786d2 |
| institution | DOAJ |
| issn | 2222-3959 2227-4898 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Press of International Journal of Ophthalmology (IJO PRESS) |
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| series | International Journal of Ophthalmology |
| spelling | doaj-art-e48619b00a194de79daacfeeee0786d22025-08-20T03:14:58ZengPress of International Journal of Ophthalmology (IJO PRESS)International Journal of Ophthalmology2222-39592227-48982025-05-0118586086710.18240/ijo.2025.05.1120250511Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label studyYao-Yao Sun0Jie Meng1Shan-Shan Li2Qin Xiao3Tian-Zi Zhang4Heng Miao5Ming-Wei Zhao6Hui-Jun Qi7Hui-Jun Qi. Department of Ophthalmology, Peking University People's Hospital, Beijing 100034, China. drqihuijun@126.comEye Institute of Shandong, State Key Laboratory Cultivation Base, Shandong Provincial Key Laboratory Cultivation Base, Shandong Provincial Key Laboratory of Ophthalmology, Qingdao 266000, Shandong Province, ChinaDepartment of Ophthalmology, Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, ChinaDepartment of Ophthalmology, Affiliated Hospital of Inner Mongolia University for the Nationalities, Tongliao 028000, Inner Mongolia Autonomous Region, ChinaDepartment of Ophthalmology, Affiliated Hospital of Inner Mongolia University for the Nationalities, Tongliao 028000, Inner Mongolia Autonomous Region, ChinaDepartment of Ophthalmology, Peking University People's Hospital, Beijing 100034, China; Beijing Key Laboratory of Ocular Disease and Optometry Science, Beijing100034, ChinaDepartment of Ophthalmology, Peking University People's Hospital, Beijing 100034, China; Beijing Key Laboratory of Ocular Disease and Optometry Science, Beijing100034, ChinaDepartment of Ophthalmology, Peking University People's Hospital, Beijing 100034, China; Beijing Key Laboratory of Ocular Disease and Optometry Science, Beijing100034, ChinaAIM: To evaluate the efficacy and safety of concurrent intravitreal ranibizumab (IVR) and extended-release dexamethasone injections (Dex-I) in naïve and refractory patients with retinal vein occlusion macular edema (RVO-ME). METHODS: This was a prospective, interventional, and open-label clinical trial. There were two groups: naïve and refractory patients (received ≥5 times of previous IVR within one year prior to enrollment) enrolled. Patients received IVR and Dex-I concurrently and re-combination therapy was required if one or more retreatment criteria were met. IVR and Dex-I were given pro re nata (PRN). The mean changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured as main outcomes. RESULTS: Totally 63 patients (63 eyes) completed the entire follow-up (31 naïve and 32 refractory patients). At month 12, the change in BCVA was greater in the naïve group than in the refractory group [19.67±11.7 (95%CI: 15.03, 24.31) letters vs 11.74±11.18 (95%CI: 7.32, 16.16) letters, P=0.014). There was no difference between the two groups of mean macular thickness reduction [364.26±215.29 (95%CI: 279.09, 449.43) μm vs 410.19±204.34 (95%CI: 329.35, 491.02) μm, P=0.43). The mean co-injection numbers were 2.52±0.58 (95%CI: 2.29, 2.75) and 2.33±0.55 (95%CI: 2.11, 2.55) in both groups (P=0.24), respectively. The retreatment interval was 115.81±13.79 d (95%CI: 110.36, 121.27) and 122.74±14.06 d (95%CI: 119.93, 133.56) in both groups (P=0.073). There was no significant difference in the incidence of glaucoma or the progression of cataracts between the two groups. CONCLUSION: In both naïve and refractory RVO-ME patients, IVR combined with Dex-I is effective. The initial combination therapy for naïve patients demonstrates more efficient improvement in BCVA and may reduce total injection numbers compared to refractory patients.http://ies.ijo.cn/en_publish/2025/5/20250511.pdfretinal vein occlusionmacular edemaprospective clinical trialanti-vascular endothelial growth factordexamethasone implant |
| spellingShingle | Yao-Yao Sun Jie Meng Shan-Shan Li Qin Xiao Tian-Zi Zhang Heng Miao Ming-Wei Zhao Hui-Jun Qi Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study International Journal of Ophthalmology retinal vein occlusion macular edema prospective clinical trial anti-vascular endothelial growth factor dexamethasone implant |
| title | Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study |
| title_full | Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study |
| title_fullStr | Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study |
| title_full_unstemmed | Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study |
| title_short | Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema: a prospective, multicenter, and interventional open-label study |
| title_sort | effect of simultaneous intravitreal ranibizumab and extended release dexamethasone injection on patients with naive versus refractory retinal vein occlusion macular edema a prospective multicenter and interventional open label study |
| topic | retinal vein occlusion macular edema prospective clinical trial anti-vascular endothelial growth factor dexamethasone implant |
| url | http://ies.ijo.cn/en_publish/2025/5/20250511.pdf |
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