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The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma

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ClinicalTrials.gov Identifier: NCT00940823
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : July 28, 2015
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Panos G. Christakis, Credit Valley EyeCare

Brief Summary:
The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from multiple study centers and randomized to a glaucoma drainage device for implantation. They will be followed long-term based upon outcome measures including intraocular pressure, glaucoma medication use, visual acuity, complications of the surgery and further treatments required.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Ahmed FP7 Valve Device: Baerveldt-350 Tube Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Ahmed Versus Baerveldt (AVB) Study: Prospective, Multicenter Trial Comparing the Ahmed-FP7 Valve With the Baerveldt-350 Implant in Treating Refractory Glaucoma
Study Start Date : July 2005
Primary Completion Date : April 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ahmed FP7 Valve
Ahmed valve glaucoma drainage device implant for treatment of refractory glaucoma.
Device: Ahmed FP7 Valve
Implantation of Ahmed FP7 Valve to lower intraocular pressure in refractory glaucoma.
Other Names:
  • New World Medical
  • AGV FP7
Active Comparator: Baerveldt-350 Tube
Baerveldt tube glaucoma drainage device implant for treatment of refractory glaucoma.
Device: Baerveldt-350 Tube
Implantation of Baerveldt-350 Tube to lower intraocular pressure in refractory glaucoma.
Other Names:
  • Advanced Medical Optics
  • BG 101-350

Primary Outcome Measures :
  1. Surgical Failure (composite measure) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 5 years ]
  2. Anti-glaucoma medications [ Time Frame: 5 years ]
  3. Visual Acuity [ Time Frame: 5 years ]
  4. Complications of surgery [ Time Frame: 5 years ]
  5. Interventions following surgery [ Time Frame: 5 years ]
  6. Non-glaucomatous complications and interventions [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater than or equal to 18.
  • Inadequately controlled glaucoma determined as intraocular pressure (IOP) greater than target, which has not responded to conventional medical and surgical therapy.
  • Patients with significant conjunctival scarring or high-risk disease (active neovascular glaucoma) precluding antimetabolite trabeculectomy will be included in the study.
  • Provide written informed consent to participate in the study.

Exclusion Criteria:

  • Age less than 18.
  • Patient will undergo an additional procedure at the time of glaucoma drainage device implantation (i.e. lensectomy, penetrating keratoplasty)
  • No light perception vision.
  • Patient has already been enrolled in the study in the contralateral eye.
  • Patient is unwilling or unable to provide informed consent to participate in the study, or adhere to the study requirements including implant randomization and required follow-up visits.

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): NCT00940823

United States, Indiana
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, United States, 46202
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Drs. Massaro and Kalenak
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Credit ValleyEC
Toronto, Ontario, Canada, L5L 1W8
Canada, Quebec
Montreal Glaucoma Institute
Montreal, Quebec, Canada, H1V 1G5
Clinic of Las Condes
Santiago, Chile
Sponsors and Collaborators
Credit Valley EyeCare
Glaucoma Research Society of Canada
Study Chair: Iqbal K Ahmed, MD University of Toronto Department of Ophthalmology & Vision Sciences
Study Director: Panos G Christakis, BS Yale School of Medicine
Principal Investigator: James C Tsai, MD Yale Ophthalmology & Visual Science
Principal Investigator: Jeffrey W Kalenak, MD Drs. Massaro & Kalenak, SC
Principal Investigator: Louis B Cantor, MD Department of Ophthalmology, Indiana University
Principal Investigator: Jeffrey A Kammer, MD Department of Ophthalmology and Visual Sciences: Vanderbilt University, School of Medicine
Principal Investigator: Paul J Harasymowycz, MD University of Montreal: Department of Ophthalmology
Principal Investigator: Juan J Mura, MD Clinic of Las Condes


Responsible Party: Panos G. Christakis, Study Director, Credit Valley EyeCare
ClinicalTrials.gov Identifier: NCT00940823     History of Changes
Other Study ID Numbers: CVEC-AVB
GRSC-2005 ( Other Identifier: Glaucoma Research Society of Canada )
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Panos G. Christakis, Credit Valley EyeCare:
Glaucoma Drainage Device
Aqueous Shunt Implant
Ahmed Valve
Baerveldt Tube
Refractory Glaucoma

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases