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Recruiting NCT03648814

Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

No phase Interventional Glaucoma, Neovascular Vascular Endothelial Growth Factor Overexpression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracameral injection, Intravitreal injection.
Who it may be relevant to
Registry conditions: Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • Procedure Intracameral injection
    A/C injection of 1.25 mg/0.05 mL bevacizumab
  • Procedure Intravitreal injection
    Vitreous injection of 1.25 mg/0.05 mL bevacizumab

Primary outcome measures

  • regression of nevolascularization [Time frame: 2 months]
Secondary outcome measures (2)
  • IOP reduction [Time frame: 2 months]
  • Injection complication [Time frame: 2 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla Universi — Hat Yai

Identifiers

NCT: NCT03648814 · REC6100321

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗