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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Glaucoma
• Intervention / Treatment: Drug: Subconjunctival Avastin; Device: Ahmed Valve implant

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nariman Nassiri, MD; Phone Number: (+98) 21 8877 4143; Email: drnassirin@sbmu.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1517973813
    • Recruiting
    • Vanak Eye Surgery Center
    • Contact: Nariman Nassiri, MD; Phone Number: (+98) 21 8877 4143; Email: drnassirin@sbmu.ac.ir
    • Principal Investigator: Nader Nassiri, MD
    • Principal Investigator: Nariman Nassiri, MD
    • Principal Investigator: Mercede Majdi-N, MD
    • Principal Investigator: Arash Mazouri, MD
    • Principal Investigator: Nazanin Rahman-A, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ISA+AVI; injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant	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)
Active Comparator: AVI; Ahmed valve implant	Device: Ahmed Valve implant; 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanak Eye Surgery Center

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (Estimate): May 24, 2010

Study Record Updates

• Last Update Posted (Estimate): May 24, 2010
• Last Update Submitted That Met QC Criteria: May 21, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Intraocular pressure; VEGF-A; Ahmed valve; Neovascular Glaucoma; Uveitic glaucoma; Failed glaucoma; Subconjunctival Avastin
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: VESC# 2010-142