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Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

Primary Purpose

Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Intracameral injection

Intravitreal injection

About this trial

This is an interventional treatment trial for Glaucoma, Neovascular focused on measuring Neovascular glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intracameral injection

Intravitreal injection

Arm Description

Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection

Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection

Outcomes

Primary Outcome Measures

regression of nevolascularization

Amount of nevolascular of iris and angle regression

Secondary Outcome Measures

IOP reduction

IOP reduction at 2-month visit compare to baseline

Injection complication

Hyphema, IOP spike

Full Information

NCT ID

NCT03648814

First Posted

August 24, 2018

Last Updated

February 3, 2022

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT03648814

Brief Title

Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression

Keywords

Neovascular glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intracameral injection

Arm Type

Experimental

Arm Description

Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection

Arm Title

Intravitreal injection

Arm Type

Experimental

Arm Description

Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection

Intervention Type

Procedure

Intervention Name(s)

Intracameral injection

Intervention Description

A/C injection of 1.25 mg/0.05 mL bevacizumab

Intervention Type

Procedure

Intervention Name(s)

Intravitreal injection

Intervention Description

Vitreous injection of 1.25 mg/0.05 mL bevacizumab

Primary Outcome Measure Information:

Title

regression of nevolascularization

Description

Amount of nevolascular of iris and angle regression

Time Frame

2 months

Secondary Outcome Measure Information:

Title

IOP reduction

Description

IOP reduction at 2-month visit compare to baseline

Time Frame

2 months

Title

Injection complication

Description

Hyphema, IOP spike

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Assoc.Prof.Weerawat Kiddee, MD

Phone

+66874954626

kweerawat@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Assoc.Prof.Weerawat Kiddee, MD

Organizational Affiliation

Prince of Songkla University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University

City

Hat-yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

WEERAWAT KIDDEE, MD

Phone

66-81271-0644

kweerawat@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

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