Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema

NCT04668703 | Unknown DMC

• 1 other identifier: Yumeng Shi
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy; Cataract Diabetic

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Procedure: Conbercept intravitreal injection

cataract surgery alone

NO INTERVENTION

Subjects will undergo cataract surgery by phacoemulsification and intraocular lens implantation.

Interventions

Conbercept intravitreal injection PROCEDURE

intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery

combined cataract surgery and intravitreal Conbercept injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients sign informed consent, and are willing and able to comply with all the follow-ups
• Age ≥ 18 years , both genders
• Diagnosis of type 1 or type 2 diabetes mellitus
• Serum HbA1c ≤ 10%
• Patients with a diagnosis of DR (ETDRS 35-53) and cataract

You may not qualify if:

• CI-DME
• Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy
• History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases
• Received anti- VEGF treatment (including intravitreal injection or systematic application) within three months prior to enrollment
• History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to enrollment, or possibly need panretinal photocoagulation of the study eye during the study
• Intraocular conventional surgery within the past three months
• Traumatic cataract or congenital bilateral cataract in the study eye
• Active ocular or periocular infection in either eye
• Iris neovascularization in the study eye
• Uncontrolled glaucoma, or history of glaucoma surgery
• Aphakia in the study eye
• History of vitrectomy in the study eye
• The density of corneal endothelial cells is lower than 2000/mm2
• Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis, or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
• Any surgical contraindications

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Related Publications (8)

• 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.

  PMID: 32402554 BACKGROUND

• 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.

  PMID: 29902977 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.

  PMID: 28151747 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.

  PMID: 29144826 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.

  PMID: 31137510 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.

  PMID: 27651226 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.

  PMID: 28284785 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.

  PMID: 28764888 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

KH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Jin Yang, MD, ph.D.

  Eye & ENT Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

Jin Yang, MD, ph.D.

CONTACT

+8613671632525; jin_er76@hotmail.com

Yumeng Shi, MD

CONTACT

+8619945616479; mengmenger123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: January 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share