Intravitreal Conbercept After Vitrectomy
Primary Purpose
Early Proliferative Diabetic Retinopathy
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Conbercept
Sponsored by
About this trial
This is an interventional treatment trial for Early Proliferative Diabetic Retinopathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Conbercept
control group
Arm Description
intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery
Pars plana vitrectomy alone
Outcomes
Primary Outcome Measures
best corrected visual acuity
BCVA using a Landolt C acuity chart method
Secondary Outcome Measures
postoperative complications
postoperative complications
central retinal thickness
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images
Full Information
NCT ID
NCT03426540
First Posted
January 26, 2018
Last Updated
April 29, 2019
Sponsor
Tianjin Medical University Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03426540
Brief Title
Intravitreal Conbercept After Vitrectomy
Official Title
Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Proliferative Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conbercept
Arm Type
Experimental
Arm Description
intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery
Arm Title
control group
Arm Type
No Intervention
Arm Description
Pars plana vitrectomy alone
Intervention Type
Drug
Intervention Name(s)
Conbercept
Intervention Description
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 Outcome Measure Information:
Title
best corrected visual acuity
Description
BCVA using a Landolt C acuity chart method
Time Frame
baseline to 24 weeks post-surgery
Secondary Outcome Measure Information:
Title
postoperative complications
Description
postoperative complications
Time Frame
baseline to 24 weeks post-surgery
Title
central retinal thickness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong X Li, MD,PhD
Organizational Affiliation
Tianjin Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Intravitreal Conbercept After Vitrectomy
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