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

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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

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:

Syed HM, Law SK, Nam SH, Li G, Caprioli J, Coleman A. Baerveldt-350 implant versus Ahmed valve for refractory glaucoma: a case-controlled comparison. J Glaucoma. 2004 Feb;13(1):38-45.

Wang JC, See JL, Chew PT. Experience with the use of Baerveldt and Ahmed glaucoma drainage implants in an Asian population. Ophthalmology. 2004 Jul;111(7):1383-8.

Tsai JC, Johnson CC, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma: a single-surgeon comparison of outcome. Ophthalmology. 2003 Sep;110(9):1814-21.

Tsai JC, Johnson CC, Kammer JA, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma II: longer-term outcomes from a single surgeon. Ophthalmology. 2006 Jun;113(6):913-7.

Goulet RJ 3rd, Phan AD, Cantor LB, WuDunn D. Efficacy of the Ahmed S2 glaucoma valve compared with the Baerveldt 250-mm2 glaucoma implant. Ophthalmology. 2008 Jul;115(7):1141-7. Epub 2007 Dec 27.

Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, Bacharach J, Panek WC. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995 Jul;120(1):23-31. Erratum in: Am J Ophthalmol. 1995 Nov;120(5):684.

Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999 Jan;127(1):27-33.

Krishna R, Godfrey DG, Budenz DL, Escalona-Camaaño E, Gedde SJ, Greenfield DS, Feuer W, Scott IU. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001 Mar;108(3):621-6.

Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, LaBree L, Heuer DK. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994 Aug;101(8):1456-63; discussion 1463-4.

Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, Varma R. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999 Dec;106(12):2312-8.

Nouri-Mahdavi K, Caprioli J. Evaluation of the hypertensive phase after insertion of the Ahmed Glaucoma Valve. Am J Ophthalmol. 2003 Dec;136(6):1001-8.

Law SK, Nguyen A, Coleman AL, Caprioli J. Comparison of safety and efficacy between silicone and polypropylene Ahmed glaucoma valves in refractory glaucoma. Ophthalmology. 2005 Sep;112(9):1514-20.

Ayyala RS, Harman LE, Michelini-Norris B, Ondrovic LE, Haller E, Margo CE, Stevens SX. Comparison of different biomaterials for glaucoma drainage devices. Arch Ophthalmol. 1999 Feb;117(2):233-6.

Ayyala RS, Michelini-Norris B, Flores A, Haller E, Margo CE. Comparison of different biomaterials for glaucoma drainage devices: part 2. Arch Ophthalmol. 2000 Aug;118(8):1081-4.

Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK 2nd, Heuer DK, Brandt JD; Tube Versus Trabeculectomy Study Group. The tube versus trabeculectomy study: design and baseline characteristics of study patients. Am J Ophthalmol. 2005 Aug;140(2):275-87.

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):23-31. Epub 2006 Sep 1.

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):9-22. Epub 2006 Sep 1.

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:	February 8, 2012
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 May 16, 2013