Intravitreal Conbercept After Vitrectomy

Early Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426540
• Other study ID #: 2016KY-09
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: Tianjin Medical University Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2019
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Early Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity	BCVA using a Landolt C acuity chart method	baseline to 24 weeks post-surgery
Secondary	postoperative complications	postoperative complications	baseline to 24 weeks post-surgery
Secondary	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