Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03633266
• Other study ID #: 10007
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2018
• Source: Wenzhou Medical University
• Contact: Yong Wei, M.D
• Phone: +86 15057551266
• Email: weiyongdoctor[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-VEGF
• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• PRP
• Retinal Diseases
• Vitrectomy

Intervention

Procedure:
• anti-VEGF
vitreoretinal surgery combined with intraoperative anti-VEGF
• PRP
vitreoretinal surgery combined with intraoperative PRP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in best-corrected visual acuity (BCVA)	Assessed using the ETDRS protocol	3 years
Secondary	Mean change from baseline in visual field	Assessed on Humphery(30-2 and 60-4)	3 years
Secondary	chang from baseline in sructure of retina	Assessed on Optical Coherence Tomography(OCT)	3 years
Secondary	chang from baseline in retinal neovascularization	Assessed on Fundus Fluorescein Angiography(FFA)	3 years