Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Vanak Eye Surgery Center40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractory Glaucoma

Interventions

Subconjunctival AvastinDRUG

Intraoperative Subconjunctival Avastin 1.25mg; single dose as an adjunct to 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Ahmed Valve implantDEVICE

184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Vanak Eye Surgery Center

Tehran, Iran

RECRUITING

Outcomes

Primary Outcomes

Change in intraocular pressure (IOP)

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.

Time frame: 12 months

Secondary Outcomes

Surgical failure

Time frame: 12 months

Change in intraocular pressure

Time frame: day 1, week 1, and months 1, 3, 6, 9

Central Contacts

Nariman Nassiri, MD

CONTACT

(+98) 21 8877 4143 drnassirin@sbmu.ac.ir

Data from ClinicalTrials.gov

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