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OpenTrials
Completed

NCT Number: NCT03426540

Intravitreal Conbercept After Vitrectomy

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.

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Key information

Age range

28 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
  • 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

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

Treatment and study plan

Conbercept

Drug

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.

Primary outcomes

  1. best corrected visual acuity

    Time frame: baseline to 24 weeks post-surgery

    BCVA using a Landolt C acuity chart method

Secondary outcomes

  1. postoperative complications

    Time frame: baseline to 24 weeks post-surgery

    postoperative complications

  2. central retinal thickness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.