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Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined cataract surgery and intravitreal Conbercept injection | Experimental | Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery. |
|
| cataract surgery alone | No Intervention | Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conbercept intravitreal injection | Procedure | intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in central retinal thickness (CRT) with optical coherence tomography (OCT) | to compare the mean change from baseline of CRT between treatment group and control group at month 1 and 3 | Baseline, 1 month and 3 month after operation |
| change in diabetic retinopathy severity score (DRSS) | to compare the mean change from baseline of DRSS between treatment group and control group at month 1 and 3 | Baseline, 1 month and 3 month after operation |
| Measure | Description | Time Frame |
|---|---|---|
| change in best corrected visual acuity (BCVA) | Baseline, 1 month and 3 month after operation | |
| change in foveal avascular zone (FAZ) with optical coherence tomography angiography (OCTA) | Baseline, 1 month and 3 month after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Yang, MD, ph.D. | Contact | +8613671632525 | jin_er76@hotmail.com | |
| Yumeng Shi, MD | Contact | +8619945616479 | mengmenger123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Yang, MD, ph.D. | Eye & ENT Hospital of Fudan University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32402554 | Background | Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127(9):1201-1210. doi: 10.1016/j.ophtha.2020.03.021. Epub 2020 Mar 29. | |
| 29902977 |
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| change in retinal vessel density (VD) with optical coherence tomography angiography (OCTA) | Baseline, 1 month and 3 month after operation |
| change in the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8 | Baseline, 1 week, 1 month and 3 month after operation |
| Zhang J, Liang Y, Xie J, Li D, Hu Q, Li X, Zheng W, He R. Conbercept for patients with age-related macular degeneration: a systematic review. BMC Ophthalmol. 2018 Jun 15;18(1):142. doi: 10.1186/s12886-018-0807-1. |
| 28151747 | Background | Relhan N, Flynn HW Jr. The Early Treatment Diabetic Retinopathy Study historical review and relevance to today's management of diabetic macular edema. Curr Opin Ophthalmol. 2017 May;28(3):205-212. doi: 10.1097/ICU.0000000000000362. |
| 29144826 | Background | Peterson SR, Silva PA, Murtha TJ, Sun JK. Cataract Surgery in Patients with Diabetes: Management Strategies. Semin Ophthalmol. 2018;33(1):75-82. doi: 10.1080/08820538.2017.1353817. Epub 2017 Nov 16. |
| 31137510 | Background | Grzybowski A, Kanclerz P, Huerva V, Ascaso FJ, Tuuminen R. Diabetes and Phacoemulsification Cataract Surgery: Difficulties, Risks and Potential Complications. J Clin Med. 2019 May 20;8(5):716. doi: 10.3390/jcm8050716. |
| 27651226 | Background | Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17. |
| 28284785 | Background | Ip MS, Zhang J, Ehrlich JS. The Clinical Importance of Changes in Diabetic Retinopathy Severity Score. Ophthalmology. 2017 May;124(5):596-603. doi: 10.1016/j.ophtha.2017.01.003. Epub 2017 Mar 8. |
| 28764888 | Background | Dhoot DS, Baker K, Saroj N, Vitti R, Berliner AJ, Metzig C, Thompson D, Singh RP. Baseline Factors Affecting Changes in Diabetic Retinopathy Severity Scale Score After Intravitreal Aflibercept or Laser for Diabetic Macular Edema: Post Hoc Analyses from VISTA and VIVID. Ophthalmology. 2018 Jan;125(1):51-56. doi: 10.1016/j.ophtha.2017.06.029. Epub 2017 Jul 29. |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C527363 | KH902 fusion protein |
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