Back to resultsPRP vs PRP+IVC for Severe nPDR
Primary Purpose
Severe Nonproliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabete Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conbercept
Panretinal coagulation
Sponsored by
About this trial
This is an interventional treatment trial for Severe Nonproliferative Diabetic Retinopathy focused on measuring Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema
Eligibility Criteria
Inclusion Criteria:
Type II diabetic patients, 18 years and older, were included if the participants had:
- severe non-PDR in either eyes with/without diabetic macular edema;
- ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
- no previous treatment (of any type) in either eye.
Exclusion Criteria:
- history of prior laser treatment or vitrectomy in the study eye;
- history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
- major surgery within the prior 6 months or planned within the next 28 days;
- history of glaucoma or ocular hypertension;
- loss of vision as a result of other causes;
- history of systemic corticosteroid therapy within the last 3 months;
- severe systemic disease other than diabetes mellitus;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin
- any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravitreal conbercept+Panretinal coagulation
Panretinal coagulation
Arm Description
Outcomes
Primary Outcome Measures
Change in best-corrected visual acuity (BCVA)
To assess the effects of two therapies on visual acuity
Secondary Outcome Measures
Change in central subfield thickness
optical coherence tomography (OCT) for the assessment of central macular thickness
Fundus fluorescein angiography
fluorescein angiography to measure area of fluorescein leakage (FLA)
Foveal avascular zone
Optical coherence tomography angiography (OCTA) for measurement of FAZ
Full Information
NCT ID
NCT03863535
First Posted
January 27, 2019
Last Updated
March 3, 2019
Sponsor
Ruijin Hospital
Collaborators
Shanghai Municipal Science and Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT03863535
Brief Title
PRP vs PRP+IVC for Severe nPDR
Official Title
Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai Municipal Science and Technology Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
Detailed Description
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Nonproliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabete Mellitus
Keywords
Conbercept, Panretinal photocoagulation, non-proliferative diabetic retinopathy, diabetic macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal conbercept+Panretinal coagulation
Arm Type
Experimental
Arm Title
Panretinal coagulation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Conbercept
Intervention Description
Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.
Intervention Type
Procedure
Intervention Name(s)
Panretinal coagulation
Intervention Description
The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.
Primary Outcome Measure Information:
Title
Change in best-corrected visual acuity (BCVA)
Description
To assess the effects of two therapies on visual acuity
Time Frame
from baseline to month 12
Secondary Outcome Measure Information:
Title
Change in central subfield thickness
Description
optical coherence tomography (OCT) for the assessment of central macular thickness
Time Frame
from baseline to month 12
Title
Fundus fluorescein angiography
Description
fluorescein angiography to measure area of fluorescein leakage (FLA)
Time Frame
from baseline to month 12
Title
Foveal avascular zone
Description
Optical coherence tomography angiography (OCTA) for measurement of FAZ
Time Frame
from baseline to month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type II diabetic patients, 18 years and older, were included if the participants had:
severe non-PDR in either eyes with/without diabetic macular edema;
ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
no previous treatment (of any type) in either eye.
Exclusion Criteria:
history of prior laser treatment or vitrectomy in the study eye;
history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
major surgery within the prior 6 months or planned within the next 28 days;
history of glaucoma or ocular hypertension;
loss of vision as a result of other causes;
history of systemic corticosteroid therapy within the last 3 months;
severe systemic disease other than diabetes mellitus;
known coagulation abnormalities or current use of anticoagulative medication other than aspirin
any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Shen, MD
Phone
+86-021-64370045
Email
carl_shen2005@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Shen, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qiong Zhang, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Shen, PhD
Phone
+86 136-2167-7680
Email
carl_shen2005@126.com
12. IPD Sharing Statement
Learn more about this trial
PRP vs PRP+IVC for Severe nPDR
We'll reach out to this number within 24 hrs