NCT03426540

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2017

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

January 26, 2018

Last Update Submit

April 29, 2019

Conditions

Early Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • best corrected visual acuity

    BCVA using a Landolt C acuity chart method

    baseline to 24 weeks post-surgery

Secondary Outcomes (2)

  • postoperative complications

    baseline to 24 weeks post-surgery

  • central retinal thickness

    baseline to 24 weeks post-surgery

Study Arms (2)

Conbercept

EXPERIMENTAL

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

Drug: Conbercept

control group

NO INTERVENTION

Pars plana vitrectomy alone

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.

Conbercept

Eligibility Criteria

Age28 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

KH902 fusion protein

Study Officials

  • Rong X Li, MD,PhD

    Tianjin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tianjin Medical University Eye Hospital

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 8, 2018

Study Start

January 1, 2017

Primary Completion

March 30, 2018

Study Completion

February 28, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share