- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648814
Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
August 15, 2025 updated by: Weerawat Kiddee, Prince of Songkla University
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
To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Assoc.Prof.Weerawat Kiddee, MD
- Phone Number: +66874954626
- Email: kweerawat@hotmail.com
Study Locations
-
-
Songkhla
-
Hat-yai, Songkhla, Thailand, 90110
- Recruiting
- Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
-
Contact:
- WEERAWAT KIDDEE, MD
- Phone Number: 66-81271-0644
- Email: kweerawat@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intracameral injection
Intracameral Bevacizumab 1.25 mg/0.05
mL.
Injection
|
A/C injection of 1.25 mg/0.05
mL bevacizumab
|
|
Experimental: Intravitreal injection
Intravitreal Bevacizumab 1.25 mg/0.05
mL.
Injection
|
Vitreous injection of 1.25 mg/0.05
mL bevacizumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
regression of nevolascularization
Time Frame: 2 months
|
Amount of nevolascular of iris and angle regression
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IOP reduction
Time Frame: 2 months
|
IOP reduction at 2-month visit compare to baseline
|
2 months
|
|
Injection complication
Time Frame: 2 days
|
Hyphema, IOP spike
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Assoc.Prof.Weerawat Kiddee, MD, Prince of Songkla University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
August 24, 2018
First Submitted That Met QC Criteria
August 24, 2018
First Posted (Actual)
August 27, 2018
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 15, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC6100321
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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