Intravitreal Conbercept After Vitrectomy

Early Phase 1

Completed

• Conditions: Early Proliferative Diabetic Retinopathy
• Interventions: Drug: Conbercept

• Registration Number: NCT03426540
• Lead Sponsor: Tianjin Medical University Eye Hospital

Brief 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.

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Primary Completion: 2018-03-30
• Study Completion: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conbercept	Conbercept	intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity	baseline to 24 weeks post-surgery	BCVA using a Landolt C acuity chart method

Secondary Outcome Measures

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