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Clinical Trials/NCT03633266
NCT03633266
Unknown
Not Applicable

Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

Wenzhou Medical University0 sites220 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anti-VEGF
Sponsor
Wenzhou Medical University
Enrollment
220
Primary Endpoint
Mean change from baseline in best-corrected visual acuity (BCVA)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
December 1, 2022
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiangtian Zhou

professor

Wenzhou Medical University

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.

Outcomes

Primary Outcomes

Mean change from baseline in best-corrected visual acuity (BCVA)

Time Frame: 3 years

Assessed using the ETDRS protocol

Secondary Outcomes

  • chang from baseline in sructure of retina(3 years)
  • Mean change from baseline in visual field(3 years)
  • chang from baseline in retinal neovascularization(3 years)

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