Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractory Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ISA+AVI

injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant

Group Type EXPERIMENTAL

Subconjunctival Avastin

Intervention Type DRUG

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)

AVI

Ahmed valve implant

Group Type ACTIVE_COMPARATOR

Ahmed Valve implant

Intervention Type DEVICE

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

Interventions

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Subconjunctival Avastin

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)

Intervention Type DRUG

Ahmed Valve implant

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes