Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

Not Applicable

• Conditions: Glaucoma, Neovascular; Vascular Endothelial Growth Factor Overexpression
• Interventions: Procedure: Intracameral injection; Procedure: Intravitreal injection

• Registration Number: NCT03648814
• Lead Sponsor: Prince of Songkla University

Brief Summary

To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.

Detailed Description

The present study comparing the safety and efficacy of 1.25mg/0.05mL Bevacizumab injection via the intracameral route versus the intravitreal route in treating the neovascular glaucoma

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Diagnosis of neovascular glaucoma
2. The patients having IOP > 21 mmHg, having the indication for trabeculectomy
3. The patients' age of at least 18-year-old
4. The patients having visual potential at least hand motion.
5. Present of NVI or NVA.
6. Willing and able to provide informed consent to participate in the study
7. Able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits

Exclusion Criteria

1. One eye patient
2. Patients having severe corneal edema or total hyphema obscure NVI or NVA view.
3. Cannot obtain endothelial cell count.
4. History of bevacizumab or fluorescence dye allergy.
5. Active infectious ocular disease including endophthalmitis and corneal ulcer
6. History of systemic disease including ischemic heart disease, cerebrovascular disease, end-stage renal disease, liver failure, uncontrolled hypertension
7. Has or planning to be pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracameral injection	Intracameral injection	Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection
Intravitreal injection	Intravitreal injection	Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection

Primary Outcome Measures

Name	Time	Method
regression of nevolascularization	2 months	Amount of nevolascular of iris and angle regression

Secondary Outcome Measures

Name	Time	Method
Injection complication	2 days	Hyphema, IOP spike
IOP reduction	2 months	IOP reduction at 2-month visit compare to baseline

Trial Locations

Locations (1)

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University; 🇹🇭 Hat-yai, Songkhla, Thailand