Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

Glaucoma, Neovascular Clinical Trial

Official title:

Efficacy and Safety of Intracameral Versus Intravitreal Bevacizumab Injection as an Adjunctive Therapy Before Trabeculectomy With Mitomycin-C in Neovascular Glaucoma: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03648814
• Other study ID #: REC6100321
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2022
• Source: Prince of Songkla University
• Contact: Assoc.Prof.Weerawat Kiddee, MD
• Phone: +66874954626
• Email: kweerawat[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Vascular Endothelial Growth Factor Overexpression

Intervention

Procedure:
• Intracameral injection
A/C injection of 1.25 mg/0.05 mL bevacizumab
• Intravitreal injection
Vitreous injection of 1.25 mg/0.05 mL bevacizumab

Locations

Country	Name	City	State
Thailand	Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University	Hat-yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regression of nevolascularization	Amount of nevolascular of iris and angle regression	2 months
Secondary	IOP reduction	IOP reduction at 2-month visit compare to baseline	2 months
Secondary	Injection complication	Hyphema, IOP spike	2 days