Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01128699

Enrollment

Registered

2010-05-24

Start date

2010-05-31

Completion date

2011-07-31

Last updated

2010-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Glaucoma

Keywords

Ahmed valve, Neovascular Glaucoma, Uveitic glaucoma, Failed glaucoma, VEGF-A, Intraocular pressure, Subconjunctival Avastin

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.

Interventions

DRUGSubconjunctival 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)

DEVICEAhmed Valve implant

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Iran

Contacts

Primary ContactNariman Nassiri, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026