IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

NCT06559488 | Completed DMC

• 1 other identifier: OPHTH-202408.01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Vitreous Hemorrhage

Keywords

Diabetic vitreous hemorrhage; Intravitreal bevacizumab; Pars plana vitrectomy; Proliferative diabetic retinopathy; Recurrent vitreous hemorrhage

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Vitreal Hemorrhage Post-Operative

  Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes

  Day 1, 7, and 30

Secondary Outcomes (1)

• Post operative visual Acuity, compared between groups

  Day 1, 7, and 30

Study Arms (2)

Bevacizumab Intravitreal

EXPERIMENTAL

Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana.

Drug: Bevacizumab Injection [Avastin]; Procedure: Pars Plana Vitrectomy

Control

EXPERIMENTAL

Eight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed.

Procedure: Pars Plana Vitrectomy

Interventions

Bevacizumab Injection [Avastin] DRUG

Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery.

Also known as: Pars Plana Vitrectomy

Bevacizumab Intravitreal

Pars Plana Vitrectomy PROCEDURE

routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients

Bevacizumab Intravitreal; Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Cicendo Eye Hospital: collaborator

Study Sites (1)

Cicendo Eye Hospital

Bandung, Jawab Barat, 40117, Indonesia

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mohamad Eko Prayogo, MD

  Faculty of Medicine Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While it was not possible to mask participants and surgeons to the treatment allocation due to the nature of the surgical intervention, efforts were made to mask the outcome assessors. This involved: Centralized Data Collection: All data related to patient outcomes (visual acuity, VH grading, complications) were collected on standardized forms and sent to a central data management center. Coded Data Entry: Patient identification numbers were used instead of names to prevent bias. Masked Data Analysis: The statistician conducting the analysis was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: April 2, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

ID (1)