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Intravitreal Conbercept After Vitrectomy

NCT ID: NCT03426540

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-02-28

Brief Summary

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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

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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

Conditions

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Early Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conbercept

intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery

Group Type EXPERIMENTAL

Conbercept

Intervention Type 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.

control group

Pars plana vitrectomy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhenchuan Zheng

Tianjin Medical University Eye Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rong X Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University

Other Identifiers

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2016KY-09

Identifier Type: -

Identifier Source: org_study_id