Intracameral versus intravitreal bevacizumab for neovascular glaucoma

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

This study will try giving bevacizumab either into the front chamber of the eye (intracameral) or into the vitreous (intravitreal) to see which is safer and better at lowering eye pressure for adults with neovascular glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prince of Songkla University (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Hat Yai, Changwat Songkhla)
• Trial ID: NCT03648814 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial compares a single 1.25 mg/0.05 mL injection of bevacizumab delivered intracamerally versus intravitreally in adults with neovascular glaucoma and intraocular pressure above 21 mmHg who are candidates for trabeculectomy. Participants must have visible iris or angle neovascularization and at least hand-motion visual potential, and they will be followed with scheduled clinic visits for outcome assessment. Outcomes include intraocular pressure control, regression of neovascularization, need for additional glaucoma surgery, and ocular adverse events. The trial is conducted at the Glaucoma Unit, Department of Ophthalmology, Prince of Songkla University, with in-person follow-up required.

Who should consider this trial

Good fit: Adults (≥18 years) with neovascular glaucoma, IOP >21 mmHg, visible NVI or NVA, at least hand-motion visual potential, and who can give informed consent and attend follow-up at the study center.

Not a fit: Patients with a single seeing eye, severe corneal edema or total hyphema obscuring the view, active ocular infection, bevacizumab allergy, major systemic cardiovascular/renal/hepatic disease, or who are pregnant or breastfeeding are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this could identify the injection route that more quickly reduces neovascularization and lowers eye pressure, potentially improving surgical outcomes and preserving vision.

How similar studies have performed: Intravitreal bevacizumab has been widely reported to cause regression of ocular neovascularization and transient IOP lowering, whereas intracameral use has been described in smaller series and direct randomized comparisons are limited.

Eligibility criteria

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

Where this trial is running

Hat Yai, Changwat Songkhla

• Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University — Hat Yai, Changwat Songkhla, Thailand (Recruiting)

Study contacts

• Principal investigator: Assoc.Prof.Weerawat Kiddee, MD — Prince of Songkla University
• Study coordinator: Assoc.Prof.Weerawat Kiddee, MD

Conditions Glaucoma, Neovascular; Vascular Endothelial Growth Factor Overexpression; Neovascular glaucoma