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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Panos G. Christakis, Credit Valley EyeCare
ClinicalTrials.gov Identifier:
NCT00940823
First received: July 15, 2009
Last updated: August 18, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Glaucoma
Device: Ahmed FP7 Valve
Device: Baerveldt-350 Tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Credit Valley EyeCare:

Primary Outcome Measures:
  • Surgical Failure (composite measure) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Anti-glaucoma medications [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complications of surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Interventions following surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Non-glaucomatous complications and interventions [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 238
Study Start Date: July 2005
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940823

Locations
United States, Indiana
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
University of Pittsburgh Medical Center Eye Center
Pittsburgh, Pennsylvania, United States, 15213
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
Chile
Clinic of Las Condes
Santiago, Chile
Sponsors and Collaborators
Credit Valley EyeCare
Glaucoma Research Society of Canada
Investigators
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
  More Information

Publications:

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
Study First Received: July 15, 2009
Last Updated: August 18, 2013
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by Credit Valley EyeCare:
Glaucoma Drainage Device
Aqueous Shunt Implant
Ahmed Valve
Baerveldt Tube
Refractory Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014