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

NCT00940823 | Completed Results

• 2 other identifiers: CVEC-AVBGRSC-2005
• Study Type: interventional
• Target: 238
• Locations: 3 countries
• Sites: 6

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.

Conditions

Glaucoma

Keywords

Glaucoma Drainage Device; Aqueous Shunt Implant; Ahmed Valve; Baerveldt Tube; Refractory Glaucoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Failure (Composite Measure)

  1. IOP out of target range (5-18 mmHg inclusive) or \<20% reduction from baseline for 2 consecutive visits after 3 months. 2. De novo glaucoma surgery required (e.g., cyclodestructive procedure, additional tube shunt). 3. Removal of the implant. 4. Severe vision loss related to the surgery (endophthalmitis, suprachoroidal hemorrhage with vision loss, enucleation, evisceration, or phthisis bulbi) or progression to no light perception for any reason.

  5 years

Secondary Outcomes (5)

• Intraocular Pressure (IOP)

  5 years

• Anti-glaucoma Medications

  5 years

• LogMAR Snellen Visual Acuity

  5 years

• Number of Participants With Complications During or After Surgery

  5 years

• Number of Participants With Interventions After Surgery

  5 years

Study Arms (2)

Ahmed FP7 Valve

ACTIVE COMPARATOR

Ahmed valve glaucoma drainage device implant for treatment of refractory glaucoma.

Device: Ahmed FP7 Valve

Baerveldt-350 Tube

ACTIVE COMPARATOR

Baerveldt tube glaucoma drainage device implant for treatment of refractory glaucoma.

Device: Baerveldt-350 Tube

Interventions

Ahmed FP7 Valve DEVICE

Implantation of Ahmed FP7 Valve to lower intraocular pressure in refractory glaucoma.

Also known as: New World Medical, AGV FP7

Ahmed FP7 Valve

Baerveldt-350 Tube DEVICE

Implantation of Baerveldt-350 Tube to lower intraocular pressure in refractory glaucoma.

Also known as: Advanced Medical Optics, BG 101-350

Baerveldt-350 Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Credit Valley EyeCare: lead
• Glaucoma Research Society of Canada: collaborator

Study Sites (6)

Eugene and Marilyn Glick Eye Institute

Indianapolis, Indiana, 46202, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

Drs. Massaro and Kalenak

Milwaukee, Wisconsin, 53226, United States

Location

Credit ValleyEC

Toronto, Ontario, L5L 1W8, Canada

Location

Montreal Glaucoma Institute

Montreal, Quebec, H1V 1G5, Canada

Location

Clinic of Las Condes

Santiago, Chile

Location

Related Publications (21)

• 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. doi: 10.1097/00061198-200402000-00008.

  PMID: 14704542 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2003.11.005.

  PMID: 15234141 BACKGROUND

• 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. doi: 10.1016/S0161-6420(03)00574-8.

  PMID: 13129882 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2006.02.029.

  PMID: 16751034 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2007.10.034. Epub 2007 Dec 27.

  PMID: 18164068 BACKGROUND

• 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. doi: 10.1016/s0002-9394(14)73755-9.

  PMID: 7611326 BACKGROUND

• 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. doi: 10.1016/s0002-9394(98)00394-8.

  PMID: 9932995 BACKGROUND

• Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano 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. doi: 10.1016/s0161-6420(00)00537-6.

  PMID: 11237919 BACKGROUND

• 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. doi: 10.1016/s0161-6420(94)31152-3.

  PMID: 8058290 BACKGROUND

• 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. doi: 10.1016/S0161-6420(99)90532-8.

  PMID: 10599663 BACKGROUND

• 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. doi: 10.1016/s0002-9394(03)00630-5.

  PMID: 14644209 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2005.04.012.

  PMID: 16005977 BACKGROUND

• 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. doi: 10.1001/archopht.117.2.233.

  PMID: 10037569 BACKGROUND

• 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. doi: 10.1001/archopht.118.8.1081.

  PMID: 10922202 BACKGROUND

• 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. doi: 10.1016/j.ajo.2005.03.031.

  PMID: 16086949 BACKGROUND

• 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. doi: 10.1016/j.ajo.2006.07.022. Epub 2006 Sep 1.

  PMID: 17054896 BACKGROUND

• 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. doi: 10.1016/j.ajo.2006.07.020. Epub 2006 Sep 1.

  PMID: 17083910 BACKGROUND

• Christakis PG, Tsai JC, Zurakowski D, Kalenak JW, Cantor LB, Ahmed II. The Ahmed Versus Baerveldt study: design, baseline patient characteristics, and intraoperative complications. Ophthalmology. 2011 Nov;118(11):2172-9. doi: 10.1016/j.ophtha.2011.05.003. Epub 2011 Sep 9.

  PMID: 21906813 RESULT

• Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, Ahmed II. The Ahmed Versus Baerveldt study: one-year treatment outcomes. Ophthalmology. 2011 Nov;118(11):2180-9. doi: 10.1016/j.ophtha.2011.05.004. Epub 2011 Sep 1.

  PMID: 21889801 RESULT

• Christakis PG, Tsai JC, Kalenak JW, Zurakowski D, Cantor LB, Kammer JA, Ahmed II. The Ahmed versus Baerveldt study: three-year treatment outcomes. Ophthalmology. 2013 Nov;120(11):2232-40. doi: 10.1016/j.ophtha.2013.04.018. Epub 2013 Jun 21.

  PMID: 23796764 RESULT

• Christakis PG, Kalenak JW, Tsai JC, Zurakowski D, Kammer JA, Harasymowycz PJ, Mura JJ, Cantor LB, Ahmed II. The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes. Ophthalmology. 2016 Oct;123(10):2093-102. doi: 10.1016/j.ophtha.2016.06.035. Epub 2016 Aug 17.

  PMID: 27544023 RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Limitations and Caveats

1. Using predetermined IOP cutoffs may not reflect individual patient outcomes. 2. Visual field progression was not an outcome criteria due to the poor baseline vision of patients. 3. Results can only be applied to patients with advanced glaucoma.

Results Point of Contact

• Title: Dr. Iqbal Ike K. Ahmed
• Organization: Prism Eye Institute

ike.ahmed@utoronto.ca

905-456-3937

Study Officials

• Iqbal K Ahmed, MD

  University of Toronto Department of Ophthalmology & Vision Sciences

  STUDY CHAIR

• Panos G Christakis, BS

  Yale University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: July 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Locations

US (3); CA (2); CL (1)