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

NCT ID: NCT04668703

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema Diabetic Retinopathy Cataract Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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combined cataract surgery and intravitreal Conbercept injection

Subjects will receive conbercept injections at a dose of 0.5 mg/eye at the conclusion of cataract surgery.

Group Type EXPERIMENTAL

Conbercept intravitreal injection

Intervention Type PROCEDURE

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

cataract surgery alone

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Conbercept intravitreal injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Uncontrolled Blood Pressure
* Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
* Renal Failure
* Pregnant or breast-feeding women
* Participation in another simultaneous medical investigator or trial
* Other situations where the researcher judges that the patient is not suitable for inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Yang, MD, ph.D.

Role: STUDY_CHAIR

Eye & ENT Hospital of Fudan University

Central Contacts

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Jin Yang, MD, ph.D.

Role: CONTACT

Phone: +8613671632525

Email: [email protected]

Yumeng Shi, MD

Role: CONTACT

Phone: +8619945616479

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 32402554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29902977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28151747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29144826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31137510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27651226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28284785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28764888 (View on PubMed)

Other Identifiers

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Yumeng Shi

Identifier Type: -

Identifier Source: org_study_id