Intravitreal Conbercept After Vitrectomy

Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy

To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).

Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.

Study Overview

• Status: Completed
• Conditions: Early Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: Conbercept

Detailed Description

The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.

At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.

The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
2. Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.

Exclusion Criteria:

1. A history of previous PPV;
2. Severe intraoperative complications
3. Postoperative silicone oil tamponade;
4. Menstruation;
5. Stroke, a thromboembolic event, or myocardial infarction in the previous
6. months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conbercept; intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery	Drug: Conbercept; Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
No Intervention: control group; Pars plana vitrectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity	BCVA using a Landolt C acuity chart method	baseline to 24 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications	baseline to 24 weeks post-surgery
central retinal thickness	Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images	baseline to 24 weeks post-surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital
• Investigators: Principal Investigator: Rong X Li, MD,PhD, Tianjin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2016KY-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No