The Effect of IVA for Preventing Postvitrectomy Hemorrhage in PDR

NCT05478967 | Completed

• 1 other identifier: IVAPDR
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Aflibercept, a recombinant fusion antibody that binds to all subtypes of VEGF and PlGF, has been shown to induce effective regression of retinal neovascularization secondary to PDR but there had been lack of a well-structured prospective study about adjunctive use of intravitreal injection of Aflibercept (IVA) to reduce postoperative VH in PPV for PDR. In this study, we aim to assess the effect of preoperative IVA on the incidence of postoperative VH after PPV for PDR.

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy; vitrectomy; Aflibercept; intravitreal injection; postvitrectomy hemorrhage

Outcome Measures

Primary Outcomes (1)

• Incidence of VH

  Postoperative VH was defined as a new episode of VH of grade 1 or above occurring later than 3 days after primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system.

  one month after vitrectomy

Secondary Outcomes (1)

• Changes of BCVA

  1 week, 1 month, 2 months and 3 months after vitrectomy

Study Arms (2)

IVA group

EXPERIMENTAL

Received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery)

Procedure: IVA injection before vitrectomy

control group

NO INTERVENTION

Did not receive IVA injection before vitrectomy

Interventions

IVA injection before vitrectomy PROCEDURE

Patients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery)

IVA group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes mellitus
• age between 35 and 65
• PDR who underwent primary pars plana vitrectomy for VH.

You may not qualify if:

• eyes with retinal tear
• eyes with iris or anterior angle neovascularization
• eyes with intraoperative use of silicone oil
• eyes with choroidal or retinal disease other than PDR or any inflammation condition
• eyes underwent any previous vitrectomy or scleral buckle surgery
• eyes received intraocular TA injection within 90 days before screening
• eyes received intraocular anti VEGF treatment within 60 days before screening or contralateral eyes received intraocular anti VEGF treatment during follow-up
• patients who had taken aspirin orally within 7 days before screening
• patient has coagulation mechanism disorder or other medicine for anticoagulant treatment
• cerebrovascular accident and / or myocardial infarction occurred within 180 days before screening
• patients with uncontrolled blood pressure (sitting position \> 160 / 100 mmHg)
• patients with liver or kidney dysfunction or any severe systemic disease.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shanghai 10th People's Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Nanjing Medical University: collaborator
• Xiamen University: collaborator

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: August 8, 2019
• Primary Completion: January 20, 2021
• Study Completion: February 20, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)