Intravitreal Conbercept After Vitrectomy

Early Phase 1CompletedNCT03426540

Tianjin Medical University Eye Hospital50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Early Proliferative Diabetic Retinopathy

Interventions

ConberceptDRUG

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.

Eligibility

Sex: ALLMin age: 28 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

best corrected visual acuity

BCVA using a Landolt C acuity chart method

Time frame: baseline to 24 weeks post-surgery

Secondary Outcomes

postoperative complications

Time frame: 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

Time frame: baseline to 24 weeks post-surgery

Data from ClinicalTrials.gov

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