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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
  Purpose

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 Intervention Phase
Refractory Glaucoma
 Drug: Subconjunctival Avastin
Device: Ahmed Valve implant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma: a Randomized Controlled Clinical Trial

Resource links provided by NLM:

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

Further study details as provided by Vanak Eye Surgery Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 21, 2010
Last Updated: May 21, 2010
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)

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013