Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05478967 |
| Other study ID # |
IVAPDR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 8, 2019 |
| Est. completion date |
February 20, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Peking University People's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
