Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

Not Applicable

• Conditions: Proliferative Diabetic Retinopathy; Anti-VEGF; Vitrectomy; PRP
• Interventions: Procedure: anti-VEGF; Procedure: PRP

• Registration Number: NCT03633266
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-17
• Study Start: 2018-09-01
• Primary Completion: 2020-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Age≥18 years old;
2. type 1 or type 2 diabetes.
3. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
4. The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus

Exclusion Criteria

1. Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
2. Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
3. anterior chamber neovascularization or neovascular glaucoma;
4. other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
5. received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-VEGF	anti-VEGF	experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF
PRP	PRP	Control group: vitreoretinal surgery combined with intraoperative PRP

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in best-corrected visual acuity (BCVA)	3 years	Assessed using the ETDRS protocol

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in visual field	3 years	Assessed on Humphery(30-2 and 60-4)
chang from baseline in sructure of retina	3 years	Assessed on Optical Coherence Tomography(OCT)
chang from baseline in retinal neovascularization	3 years	Assessed on Fundus Fluorescein Angiography(FFA)