Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Refractory Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01128699
• Other study ID #: VESC# 2010-142
• Status: Recruiting
• Phase: Phase 3
• First received: May 21, 2010
• Last updated: May 21, 2010
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2010
• Source: Vanak Eye Surgery Center
• Contact: Nariman Nassiri, MD
• Phone: (+98) 21 8877 4143
• Email: drnassirin[@]sbmu.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee of Shaheed Beheshti University of Medical Sciences (www.orcir.org)Iran: Institutional Review Board of Vanak Eye Surgery Center (www.VESC.ir)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Refractory Glaucoma

Intervention

Drug:
• 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)

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Vanak Eye Surgery Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Vanak Eye Surgery Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	Yes
Secondary	Surgical failure		12 months	Yes
Secondary	Change in intraocular pressure		day 1, week 1, and months 1, 3, 6, 9	Yes