Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

Sponsor

Prince of Songkla University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03648814

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Neovascular Vascular Endothelial Growth Factor Overexpression	Procedure: Intracameral injection Procedure: Intravitreal injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracameral injection Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection	Procedure: Intracameral injection A/C injection of 1.25 mg/0.05 mL bevacizumab
Experimental: Intravitreal injection Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection	Procedure: Intravitreal injection Vitreous injection of 1.25 mg/0.05 mL bevacizumab

Arm

Intervention/Treatment

Experimental: Intracameral injection

Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection

Procedure: Intracameral injection

A/C injection of 1.25 mg/0.05 mL bevacizumab

Experimental: Intravitreal injection

Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection

Procedure: Intravitreal injection

Vitreous injection of 1.25 mg/0.05 mL bevacizumab

Outcome Measures

Primary Outcome Measures

regression of nevolascularization [2 months]
Amount of nevolascular of iris and angle regression

Secondary Outcome Measures

IOP reduction [2 months]
IOP reduction at 2-month visit compare to baseline
Injection complication [2 days]
Hyphema, IOP spike

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of neovascular glaucoma
The patients having IOP > 21 mmHg, having the indication for trabeculectomy
The patients' age of at least 18-year-old
The patients having visual potential at least hand motion.
Present of NVI or NVA.
Willing and able to provide informed consent to participate in the study
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University	Hat-yai	Songkhla	Thailand	90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

Principal Investigator: Assoc.Prof.Weerawat Kiddee, MD, Prince of Songkla University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weerawat Kiddee, Assoc. Prof., Prince of Songkla University

ClinicalTrials.gov Identifier:

NCT03648814

Other Study ID Numbers:

REC6100321

First Posted:

Aug 27, 2018

Last Update Posted:

Feb 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Weerawat Kiddee, Assoc. Prof., Prince of Songkla University

Neovascular glaucoma

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Neovascular

Study Results

No Results Posted as of Feb 7, 2022