Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Prince of Songkla University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glaucoma

Treatments: Drug: Bevacizumab; Drug: Mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01263834

EC 53-296-02-1-2

Details and patient eligibility

About

The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Full description

Prospective interventional clinical trial

Single center, outcome assessor-masked, active control, randomized controlled trial

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary open angle glaucoma with primary mmc-trabeculectomy indication

Exclusion criteria

• combined phacoemulsification with trabeculectomy
• no more than 6 month of cataract surgery before trabeculectomy
• revised trabeculectomy
• active uveitic glaucoma
• neovascular glaucoma
• par planar vitrectomy
• conjunctival surgery
• allergy to bevacizumab or mitomycin C
• ischemic heart disease
• cerebrovascular disease
• renal failure
• liver failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

39 participants in 2 patient groups

Mitomycin c

Active Comparator group

Description:

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Treatment:

Drug: Mitomycin C

Bevacizumab

Experimental group

Description:

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Treatment:

Drug: Bevacizumab