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      Efficacy and safety of conbercept as a primary treatment for choroidal neovascularization secondary to punctate inner choroidopathy

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          Abstract

          Background

          To evaluate the efficacy and safety of intravitreal conbercept (KH902) as the primary treatment of choroidal neovascularization secondary to punctate inner choroidopathy.

          Methods

          This study was a retrospective, consecutive, observational case series. We reviewed medical records of 16 eyes (16 patients) with naive subfoveal or juxtafoveal choroidal neovascularization secondary to punctuate inner choroidopathy that were treated with intravitreal conbercept injections. All patients completed at least six months of follow-up. Best-corrected visual acuity (BCVA) was measured, and anatomical features were assessed with fluorescein angiography, indocyanine green angiography, and optical coherence tomography.

          Results

          At the month-6 follow-up visit, best-corrected visual acuity improved from 0.70 ± 0.36 (with approximate Snellen equivalent of 20/100) to 0.44 ± 0.25 (20/50 in Snellen) logarithm of the minimum angle of resolution (logMAR) ( P = 0.003). Mean improvement of vision was 2.6 lines, with 50% treated eyes (8 eyes of 16) showing an improvement of ≥3 lines and 62.5% (10 eyes of 16), obtaining an improvement of ≥2 lines; all 16 eyes had stable or improved vision. Mean central retinal thickness decreased from 294.94 ± 102.68 μm to 206.56 ± 61.71 μm ( P = 0.005). Fifteen eyes (93.75%) showed absence of CNV leakage at the end of the study period. No conbercrept-related systemic or ocular adverse events were observed.

          Conclusion

          Intravitreal injection of conbercept significantly improved visual and anatomical outcomes in choroidal neovascularization secondary to punctate inner choroidopathy over a 6-month follow-up period.

          Trial registration

          ISRCTN85678307, retrospectively registered on May 11, 2017.

          Related collections

          Most cited references28

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          Safety and efficacy of conbercept in neovascular age-related macular degeneration: results from a 12-month randomized phase 2 study: AURORA study.

          To assess the safety and efficacy of multiple injections of 0.5 and 2.0 mg conbercept using variable dosing regimens in patients with neovascular age-related macular degeneration (AMD).
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            A phase 1 study of KH902, a vascular endothelial growth factor receptor decoy, for exudative age-related macular degeneration.

            To determine the safety, tolerability, and bioactivity of KH902, a fully human fusion protein containing key domains from vascular endothelial growth factor receptors 1 and 2 with human immunoglobulin Fc. Prospective, single-center, open-label, dose-escalating, interventional case series. Twenty-eight patients with choroidal neovascularization (CNV) resulting from exudative age-related macular degeneration (AMD) with lesion size of 12 disc areas or less and best-corrected visual acuity (VA) of 55 letters or worse. A single intravitreal injection of KH902 at 1 of 6 escalating doses if no dose-limiting toxicity (DLT) occurred through postinjection day 14 of the previous dose level. Follow-up examinations were performed on postinjection days 1, 3, 5, 7, 14, 28, and 42. The primary end point was at 42 days, and patients were monitored for an additional 6 weeks (12 weeks total). The primary safety measures were changes from baseline in VA, intraocular pressure (IOP), intraocular inflammation, and production of anti-KH902 antibody. Dose-limiting toxicity was defined as intraocular inflammation, elevated IOP, significantly reduced vision, or retinal hemorrhage within 42 days after injection. Bioactivity measures included mean change from baseline in VA, central retinal thickness, and total macular volume on optical coherence tomography and CNV changes on fluorescein angiography. All patients completed the study with no DLT and no serious or drug-related adverse events. Ocular adverse events were mild to moderate in severity, including transient IOP elevation and injection-site subconjunctival hemorrhage after KH902 injections. No serum anti-KH902 antibodies were detected. On day 42 after injection, the mean change in VA from baseline was +19.6 letters with no subjects losing 1 letter or more and 57% of patients gaining 15 letters or more from baseline. The mean change in center point thickness from baseline was -77.2 μm and the mean decrease in CNV area was 12.6%. No safety concerns were detected after a single, intravitreal injection of KH902 up to 3.0 mg in this phase 1 study. Bioactivity of KH902 was suggested with improvements in VA, reduction in central retinal thickness, and a decrease in CVN area in patients with CNV resulting from exudative AMD, indicating that further study is warranted. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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              Punctate inner choroidopathy.

              Ten moderately myopic women had blurred vision, light flashes, or paracentral scotomas associated with small yellow-white lesions of the inner choroid and pigment epithelium. Most lesions had an overlying serous detachment, were hyperfluorescent, and leaked fluorescein during the acute phase. The lesions healed into atrophic scars and became progressively more pigmented with time. Subretinal neovascular membranes later developed from scars in six patients. Vision was usually only minimally affected unless the lesions were subfoveal or unless choroidal neovascular membranes subsequently occurred. Extensive laboratory studies were noncontributory.
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                Author and article information

                Contributors
                pengyuting08@163.com
                zhangxiongze@foxmail.com
                superlanmi@sina.com
                wwwlaubing@163.com
                chengguozuo@163.com
                candylee_freedom@sina.cn
                +86 20 87330292 , wenfeng208@foxmail.com
                Journal
                BMC Ophthalmol
                BMC Ophthalmol
                BMC Ophthalmology
                BioMed Central (London )
                1471-2415
                12 June 2017
                12 June 2017
                2017
                : 17
                : 87
                Affiliations
                ISNI 0000 0001 2360 039X, GRID grid.12981.33, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, , Sun Yat-sen University, ; 54 South Xianlie Road, Guangzhou, 510060 China
                Article
                481
                10.1186/s12886-017-0481-8
                5468989
                f8d5ce86-a802-4ba0-9db5-e76adbb7c6f9
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 4 March 2017
                : 30 May 2017
                Funding
                Funded by: National Natural Science Foundation of China
                Award ID: 81570831
                Award Recipient :
                Funded by: National Natural Science Foundation of China
                Award ID: 81470647
                Award Recipient :
                Funded by: Fundamental Research Funds of State Key Laboratory of Ophthalmology
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Ophthalmology & Optometry
                conbercept,kh902,intravitreal injection,choroidal neovascularization,punctate inner choroidopathy,efficacy

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