Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Phase 3

• Conditions: Refractory Glaucoma
• Interventions: Drug: Subconjunctival Avastin; Device: Ahmed Valve implant

• Registration Number: NCT01128699
• Lead Sponsor: Vanak Eye Surgery Center

Brief Summary

The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Detailed Description

Several studies have revealed evidences on the substantial role of Vascular endothelial growth factor-A (VEGF-A) in enhancing neovascularization processes. Some studies have shown the efficacy of intravitreal Avastin in reducing level of VEGF-A to improve NVG. On the other hand, recent pathological studies demonstrated that neutralization of VEGF reduced vascularity and decreased scar formation during wound healing, showing that VEGF strongly influence scar tissue formation. This may reduce the formation of encapsulated cyst after glaucoma surgeries and thus might improve the surgical success rate. The effect of subconjunctival bevacizumab as an adjunctive therapy in filtering glaucoma surgeries has been recently illustrated.

We aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Last Update Submitted: 2010-05-21
• Study First Posted: 2010-05-24
• Last Update Posted: 2010-05-24
• Primary Completion: 2011-05
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof

Exclusion Criteria

• No light perception
• elevated IOP associated with silicone oil
• previous glaucoma drainage device implantation in the same eye
• previous cyclodestructive treatment
• increased risk of endophthalmitis (e.g., active adnexal and ocular surface infection, immunosuppression, or immunodeficiency, including the use of systemic steroids)
• posterior segment disorders, or pre-existing ocular comorbidities (e.g., pterygium, phacodonesis, corneal opacity, or corneal endothelial dystrophies).

Only 1 eye per patient was included in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISA+AVI	Subconjunctival Avastin	injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant
AVI	Ahmed Valve implant	Ahmed valve implant

Primary Outcome Measures

Name	Time	Method
Change in intraocular pressure (IOP)	12 months	To demonstrate the efficacy and safety of subconjuctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Secondary Outcome Measures

Name	Time	Method
Surgical failure	12 months
Change in intraocular pressure	day 1, week 1, and months 1, 3, 6, 9

Trial Locations

Locations (1)

Vanak Eye Surgery Center; 🇮🇷 Tehran, Iran, Islamic Republic of