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Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03633266
Enrollment
220
Registered
2018-08-16
Start date
2018-09-01
Completion date
2022-12-01
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-VEGF, Proliferative Diabetic Retinopathy, PRP, Vitrectomy

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.

Interventions

PROCEDUREanti-VEGF

vitreoretinal surgery combined with intraoperative anti-VEGF

PROCEDUREPRP

vitreoretinal surgery combined with intraoperative PRP

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline in best-corrected visual acuity (BCVA)3 yearsAssessed using the ETDRS protocol

Secondary

MeasureTime frameDescription
Mean change from baseline in visual field3 yearsAssessed on Humphery(30-2 and 60-4)
chang from baseline in sructure of retina3 yearsAssessed on Optical Coherence Tomography(OCT)
chang from baseline in retinal neovascularization3 yearsAssessed on Fundus Fluorescein Angiography(FFA)

Contacts

Primary ContactYong Wei, M.D
weiyongdoctor@163.com+86 15057551266
Backup ContactWei lin, M.D
linweiysg@163.com+86 13587560390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026