Glaucoma, NeovascularNCT03648814
Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
A study testing Intracameral injection and Intravitreal injection in people with Glaucoma, Neovascular and Vascular Endothelial Growth Factor Overexpression, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression
- What is being tested?
- Intracameral injection and Intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2018to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
WEERAWAT KIDDEE, MD, 66-81271-0644, kweerawat@hotmail.com
About this study
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
To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.
Read the 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
- Being tested
- Intracameral injection, Intravitreal injection
- Keywords
- Neovascular glaucoma
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracameral injectionProcedure or surgery
A/C injection of 1.25 mg/0.05 mL bevacizumab
Intravitreal injectionProcedure or surgery
Vitreous injection of 1.25 mg/0.05 mL bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Intracameral injection | Experimental | Intracameral Bevacizumab 1.25 mg/0.05 mL. Injection Receives: Procedure: Intracameral injection |
| Intravitreal injection | Experimental | Intravitreal Bevacizumab 1.25 mg/0.05 mL. Injection Receives: Procedure: Intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
regression of nevolascularization
Amount of nevolascular of iris and angle regression
Measured: 2 months
Secondary outcomes (2)
IOP reduction
IOP reduction at 2-month visit compare to baseline
Measured: 2 months
Injection complication
Hyphema, IOP spike
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, NeovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Assoc.Prof.Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648814
- Sponsor's protocol ID
- REC6100321
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2018
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03648814
- Acronym / sponsor ID
- REC6100321
- Keywords
- Neovascular glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracameral injection | Experimental | Procedure: Intracameral injectionIntracameral Bevacizumab 1.25 mg/0.05 mL. Injection |
| Intravitreal injection | Experimental | Procedure: Intravitreal injectionIntravitreal Bevacizumab 1.25 mg/0.05 mL. Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracameral injectionA/C injection of 1.25 mg/0.05 mL bevacizumab | Procedure or surgery | Intracameral injection |
| Intravitreal injectionVitreous injection of 1.25 mg/0.05 mL bevacizumab | Procedure or surgery | Intravitreal injection |
Primary outcome
regression of nevolascularization
Time frame: 2 months
Amount of nevolascular of iris and angle regression
2 secondary outcomes
IOP reduction
Time frame: 2 months
Injection complication
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assoc.Prof.Weerawat Kiddee, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracameral injection and Intravitreal injection in people with Glaucoma, Neovascular and Vascular Endothelial Growth Factor Overexpression, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assoc.Prof.Weerawat Kiddee, MD (+66874954626, kweerawat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regression of nevolascularization (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.