Clinical trial NCT06559488: IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes
Official title: Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Vitreous Hemorrhage
Keywords: Diabetic vitreous hemorrhage
Intravitreal bevacizumab
Pars plana vitrectomy
Proliferative diabetic retinopathy
Recurrent vitreous hemorrhage
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
Collaborators: name: Cicendo Eye Hospital
First posted: 2024-08-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group design was employed. Patients requiring vitrectomy for diabetic non-clearing vitreous hemorrhage (VH) were divided into two groups:

Intervention Group: Underwent vitrectomy followed by an intravitreal injection of bevacizumab (1.25 mg/0.05 mL).

Control Group: Underwent vitrectomy alone.
Primary purpose: TREATMENT

Brief summary: Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.

Detailed description: Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.

Exclusion Criteria:

* Patients with tractional retinal detachment (ART)
* Patients with severe fibrovascular traction,
* Patients with intravitreal gas or silicone oil tamponade at the end of surgery
* Patients with other eye diseases besides diabetic vitreous hemorrhage
* Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
* Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy
* Patients with inability to attend follow-up examinations for at least 1 month
* Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)

Primary outcomes:
measure: Incidence and Severity of Vitreal Hemorrhage Post-Operative
timeFrame: Day 1, 7, and 30
Secondary outcomes:
measure: Post operative visual Acuity, compared between groups
timeFrame: Day 1, 7, and 30
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Cicendo Eye Hospital
state: Jawab Barat
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran
name: Mohamad Eko Prayogo, MD
role: PRINCIPAL_INVESTIGATOR
References: