Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
1 other identifier
interventional
220
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 17, 2018
August 1, 2018
2.3 years
August 2, 2018
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in best-corrected visual acuity (BCVA)
Assessed using the ETDRS protocol
3 years
Secondary Outcomes (3)
Mean change from baseline in visual field
3 years
chang from baseline in sructure of retina
3 years
chang from baseline in retinal neovascularization
3 years
Study Arms (2)
anti-VEGF
EXPERIMENTALexperimental group: vitreoretinal surgery combined with intraoperative anti-VEGF
PRP
ACTIVE COMPARATORControl group: vitreoretinal surgery combined with intraoperative PRP
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Wei, M.D
The Eye Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 16, 2018
Study Start
September 1, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2022
Last Updated
August 17, 2018
Record last verified: 2018-08