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Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

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ClinicalTrials.gov Identifier: NCT01128699
Recruitment Status : Unknown
Verified May 2010 by Vanak Eye Surgery Center.
Recruitment status was:  Recruiting
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Refractory Glaucoma Drug: Subconjunctival Avastin Device: Ahmed Valve implant Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial
Study Start Date : May 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. Change in intraocular pressure (IOP) [ Time Frame: 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 Outcome Measures :
  1. Surgical failure [ Time Frame: 12 months ]
  2. Change in intraocular pressure [ Time Frame: day 1, week 1, and months 1, 3, 6, 9 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128699


Contacts
Contact: Nariman Nassiri, MD (+98) 21 8877 4143 drnassirin@sbmu.ac.ir

Locations
Iran, Islamic Republic of
Vanak Eye Surgery Center Recruiting
Tehran, Iran, Islamic Republic of, 1517973813
Contact: Nariman Nassiri, MD    (+98) 21 8877 4143    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         
Sponsors and Collaborators
Vanak Eye Surgery Center
More Information

Responsible Party: Nader Nassiri, Associate Professor, Department of Ophthalmology, Imam Hossein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
ClinicalTrials.gov Identifier: NCT01128699     History of Changes
Other Study ID Numbers: VESC# 2010-142
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: May 2010

Keywords provided by Vanak Eye Surgery Center:
Ahmed valve
Neovascular Glaucoma
Uveitic glaucoma
Failed glaucoma
VEGF-A
Intraocular pressure
Subconjunctival Avastin

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents