Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Vanak Eye Surgery Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Vanak Eye Surgery Center

ClinicalTrials.gov Identifier:

NCT01128699

First received: May 21, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 21, 2010

Last Updated Date

May 21, 2010

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in intraocular pressure (IOP) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Surgical failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Change in intraocular pressure [ Time Frame: day 1, week 1, and months 1, 3, 6, 9 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Refractory Glaucoma

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: ISA+AVI
injection of intraoperative subconjunctival Avastin as an adjunct to Ahmed valve implant

Intervention: Drug: Subconjunctival Avastin
Active Comparator: AVI
Ahmed valve implant

Intervention: Device: Ahmed Valve implant

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Nariman Nassiri, MD

(+98) 21 8877 4143

drnassirin@sbmu.ac.ir

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01128699

Other Study ID Numbers ^ICMJE

VESC# 2010-142

Has Data Monitoring Committee

Yes

Responsible Party

Nader Nassiri, Associate Professor, Department of Ophthalmology, Imam Hossein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran

Study Sponsor ^ICMJE

Vanak Eye Surgery Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Vanak Eye Surgery Center

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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