Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

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

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

Study Overview

• Status: Unknown
• Conditions: Proliferative Diabetic Retinopathy; Vitrectomy; PRP; Anti-VEGF
• Intervention / Treatment: Procedure: anti-VEGF; Procedure: PRP

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-VEGF; experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF	Procedure: anti-VEGF; vitreoretinal surgery combined with intraoperative anti-VEGF
Active Comparator: PRP; Control group: vitreoretinal surgery combined with intraoperative PRP	Procedure: PRP; vitreoretinal surgery combined with intraoperative PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in best-corrected visual acuity (BCVA)	Assessed using the ETDRS protocol	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: Yong Wei, M.D, The Eye Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 10007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No