glaucoma Bevacizumab, Filtering Surgery, Minimally Invasive Surgical Procedures, Trabeculectomy, Glaucoma Drainage Implants, administration &
Conditions
Interventions
At the conclusion of the Trabeculectomy surgery, the operating surgeon will inject 1.25 mg of bevacizumab (Avastin) in a volume of 0.05 mL using a 30 gauge needle. The medication will be delivered in
Experimental Drug,Experimental Drug,Placebo Comparator Drug,Experimental Drug,Experimental Drug,Experimental Drug,Experimental Drug
Bevacizumab augmentation in Trabeculectomy
intravitreous,Bevacizumab augmentation in Trabeculectomy
intracameral,placebo (Balanced salt solution) in trabeculectomy,Bevacizumab augmentation in GDD
intracameral,placebo in GDD,Bevacizumab augmentation in MIBS
intracameral,placebo in MIBS
Sponsors
Mettapracharak hospital (Wat Rai Khing)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older diagnosed with any type of glaucoma. 2. Patients with clinical indications for glaucoma surgery, including trabeculectomy, glaucoma drainage device (GDD) implantation (Ahmed or AADI), or minimally invasive bleb surgery (MIBS) (XEN or PreserFlo). 3. If both eyes meet the eligibility criteria, only the first eye undergoing the scheduled surgery will be enrolled in the study. 4. Patients who demonstrate a thorough understanding of the disease and provide written informed consent for study participation and the disclosure of relevant medical data. 5. Patients who are able and willing to attend all scheduled postoperative follow-up visits at Mettapracharak Hospital (Wat Rai Khing) for a minimum of 6 months.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) agents. 2. Active ocular inflammation or infection. 3. Known hypersensitivity or history of allergic reactions to bevacizumab or mitomycin C (MMC). 4. Current pregnancy or breastfeeding. 5. History of systemic thromboembolism. 6. History of ocular trauma or other prior ocular surgeries, excluding uncomplicated cataract surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the changes in intraocular pressure (IOP) between the bevacizumab augmentation groups and the control group in patients undergoing trabeculectomy, GDD implantation , and MIBS 12 months postoperative mean IOP, measured IOP by Goldmann applanation tonometer or iCare tonometer if the patient cannot measure by Goldmann applanation tonometer | — |
Secondary
| Measure | Time frame |
|---|---|
| the optimal administration regimen of adjunctive bevacizumab combined with mitomycin C (MMC) in patients undergoing trabeculectomy 1, 3, 6, and 12 months postoperatively IOP reduction between intravitreal [IVT] vs. intracameral [IC] by Goldmann applanation tonometer or iCare tonometer if the patient cannot measure by Goldmann applanation tonometer ,the surgical success rates following bevacizumab augmentation in patients undergoing GDD implantation (Ahmed, AADI), MIBS (XEN, PreserFlo), and trabeculectomy. 1, 3, 6, and 12 months postoperatively Complete Success-IOP between 6-21 mmHg without the any postoperative IOP-lowering medications. Qualified Success: IOP between 6-21 mmHg. Failure: the patient that not meet success criteria.,To compare the number of postoperative IOP-lowering medications and complication rates between the bevacizumab-treated groups and the control groups 1, 3, 6, and 12 months postoperatively mean number of medications and complication noted via medical record | — |
Countries
Thailand
Contacts
Public ContactHataipat Labpornsirikul
Mettapracharak Hospital
Outcome results
None listed