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Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT03633266
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, 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.

Condition or disease Intervention/treatment Phase
Anti-VEGF Proliferative Diabetic Retinopathy PRP Vitrectomy Procedure: anti-VEGF Procedure: PRP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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




Primary Outcome Measures :
  1. Mean change from baseline in best-corrected visual acuity (BCVA) [ Time Frame: 3 years ]
    Assessed using the ETDRS protocol


Secondary Outcome Measures :
  1. Mean change from baseline in visual field [ Time Frame: 3 years ]
    Assessed on Humphery(30-2 and 60-4)

  2. chang from baseline in sructure of retina [ Time Frame: 3 years ]
    Assessed on Optical Coherence Tomography(OCT)

  3. chang from baseline in retinal neovascularization [ Time Frame: 3 years ]
    Assessed on Fundus Fluorescein Angiography(FFA)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633266


Contacts
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Contact: Yong Wei, M.D +86 15057551266 weiyongdoctor@163.com
Contact: Wei lin, M.D +86 13587560390 linweiysg@163.com

Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: Yong Wei, M.D The Eye Hospital of Wenzhou Medical University

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Responsible Party: Xiangtian Zhou, professor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03633266     History of Changes
Other Study ID Numbers: 10007
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors