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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
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

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

First Posted
August 24, 2018
Last Updated
February 3, 2022
Sponsor
Prince of Songkla University
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Email
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
Email
kweerawat@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

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