The Effect of IVA for Preventing Postvitrectomy Hemorrhage in PDR

NCT ID: NCT05478967

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2021-02-20

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.

Detailed Description

The enrolled eyes were randomly assigned according to the Central Randomization System with a ratio of 1∶1 to IVA group and control group. Patients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery); patients in control group did not receive IVA injection before vitrectomy. The preoperative IVA injection was performed following a standard protocol. All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge trocar and cannula system under local or anesthesia. Procedures such as fibrovascular membrane dissection, endodiathermy, or endolaser photocoagulation were performed with 25-gauge instruments as required. Intraoperative bleeding was controlled by either endodiathermy or increasing the irrigation pressure. Patients were examined 1 week, 1 month, 2 months, and 3 months after surgery if there were no postoperative events. If postoperative complications, including VH, occurred, patients were instructed to visit the clinic regardless of the visit schedule. At each visit, any events involving the study eye between the visit schedules were recorded accordingly. At each postoperative visit, slit-lamp biomicroscope, indirect ophthalmoscopy, and fundus photographs were performed. The primary outcome of this study was incidence of VH after vitrectomy.

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. Incidence of VH at week 1, month 1, month 2 and month 3 were recorded. In the case of gas-injected eye, complications were assessed in the region without the gas bubble.

Preoperative, intraoperative, and postoperative data were collected for each patient. Preoperative data included age; sex; duration and status of diabetes mellitus (HbA1C); other systemic diseases such as hypertension and renal function (serum creatinine); and ophthalmic parameters including best-corrected visual acuity (BCVA), intraocular pressure (IOP), lens status, previous pan-retinal photocoagulation (PRP), and indication for surgery. Intraoperative data included phacoemulsification and intraocular lens (IOL) procedures, SF6 or air tamponade, and the presence of fibrovascular proliferation and tractional retinal detachment. Postoperative data included BCVA at each visit and number of episodes of complications.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

IVA group

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

Group Type: EXPERIMENTAL

IVA injection before vitrectomy

Intervention Type: PROCEDURE

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

control group

Did not receive IVA injection before vitrectomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IVA injection before vitrectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Xiamen University

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinfeng Qu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

People's Hospital of Peking University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

IVAPDR

Identifier Type: -

Identifier Source: org_study_id