Back to resultsAnti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Primary Purpose
Anti-VEGF, Proliferative Diabetic Retinopathy, PRP
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anti-VEGF
PRP
Sponsored by
About this trial
This is an interventional treatment trial for Anti-VEGF
Eligibility Criteria
Inclusion Criteria:
- Age≥18 years old;
- type 1 or type 2 diabetes.
- proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
- The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus
Exclusion Criteria:
- Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
- Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
- anterior chamber neovascularization or neovascular glaucoma;
- other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
- received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anti-VEGF
PRP
Arm Description
experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF
Control group: vitreoretinal surgery combined with intraoperative PRP
Outcomes
Primary Outcome Measures
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
Secondary Outcome Measures
Mean change from baseline in visual field
Assessed on Humphery(30-2 and 60-4)
chang from baseline in sructure of retina
Assessed on Optical Coherence Tomography(OCT)
chang from baseline in retinal neovascularization
Assessed on Fundus Fluorescein Angiography(FFA)
Full Information
NCT ID
NCT03633266
First Posted
August 2, 2018
Last Updated
August 15, 2018
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03633266
Brief Title
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Official Title
Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-VEGF, Proliferative Diabetic Retinopathy, PRP, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-VEGF
Arm Type
Experimental
Arm Description
experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
Control group: vitreoretinal surgery combined with intraoperative PRP
Intervention Type
Procedure
Intervention Name(s)
anti-VEGF
Intervention Description
vitreoretinal surgery combined with intraoperative anti-VEGF
Intervention Type
Procedure
Intervention Name(s)
PRP
Intervention Description
vitreoretinal surgery combined with intraoperative PRP
Primary Outcome Measure Information:
Title
Mean change from baseline in best-corrected visual acuity (BCVA)
Description
Assessed using the ETDRS protocol
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Mean change from baseline in visual field
Description
Assessed on Humphery(30-2 and 60-4)
Time Frame
3 years
Title
chang from baseline in sructure of retina
Description
Assessed on Optical Coherence Tomography(OCT)
Time Frame
3 years
Title
chang from baseline in retinal neovascularization
Description
Assessed on Fundus Fluorescein Angiography(FFA)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 years old;
type 1 or type 2 diabetes.
proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus
Exclusion Criteria:
Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
anterior chamber neovascularization or neovascular glaucoma;
other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Wei, M.D
Phone
+86 15057551266
Email
weiyongdoctor@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei lin, M.D
Phone
+86 13587560390
Email
linweiysg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Wei, M.D
Organizational Affiliation
The Eye Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
We'll reach out to this number within 24 hrs