Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

NCT03633266 — Not applicable, Unknown, 220 participants, Wenzhou Medical University

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

Registry	NCT03633266
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	220 (Estimated)
Sponsor	Wenzhou Medical University (Other)
Conditions	Anti-VEGF, Proliferative Diabetic Retinopathy, PRP, Vitrectomy
Interventions	anti-VEGF, PRP (Procedure)
Dates	start 2018-09-01 (estimated), primary completion 2020-12-01 (estimated), completion 2022-12-01 (estimated), first posted 2018-08-16, last updated 2018-08-17

-Summary

To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.

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+Arms and interventions

Arm	Type	Interventions	Description
anti-VEGF	Experimental	Procedure: anti-VEGF	experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF
PRP	Active comparator	Procedure: PRP	Control group: vitreoretinal surgery combined with intraoperative PRP

anti-VEGF (Procedure): vitreoretinal surgery combined with intraoperative anti-VEGF
PRP (Procedure): vitreoretinal surgery combined with intraoperative PRP

+Outcome measures

Primary outcomes

Mean change from baseline in best-corrected visual acuity (BCVA) [3 years]: Assessed using the ETDRS protocol

Secondary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Investigators

Yong Wei, M.D, Principal investigator, The Eye Hospital of Wenzhou Medical University

My Notes

Public

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