Trial Outcomes & Findings for The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma (NCT NCT00940823)

Last Updated: 2018-03-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

238 participants

Primary outcome timeframe

5 years

Results posted on

2018-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ahmed Group Ahmed FP7 Valve Implant	Baerveldt Group Baerveldt-350 Implant
Overall Study STARTED	124	114
Overall Study COMPLETED	89	82
Overall Study NOT COMPLETED	35	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Ahmed Group Ahmed FP7 Valve Implant	Baerveldt Group Baerveldt-350 Implant
Overall Study Death	8	12
Overall Study Lost to Follow-up	27	20

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ahmed Group n=124 Participants Patients received an Ahmed-FP7 valve implant at the time of surgery.	Baerveldt Group n=114 Participants Patients received a Baerveldt-350 implant at the time of surgery.	Total n=238 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 17 • n=5 Participants	67 years STANDARD_DEVIATION 15 • n=7 Participants	66 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	73 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	41 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	86 Participants n=7 Participants	182 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Intraocular Pressure	31.1 mmHg STANDARD_DEVIATION 10.5 • n=5 Participants	31.7 mmHg STANDARD_DEVIATION 11.1 • n=7 Participants	31.4 mmHg STANDARD_DEVIATION 10.8 • n=5 Participants
Glaucoma Medication Use	3.1 medications STANDARD_DEVIATION 1.0 • n=5 Participants	3.1 medications STANDARD_DEVIATION 1.1 • n=7 Participants	3.1 medications STANDARD_DEVIATION 1.0 • n=5 Participants
Prior Laser Therapies	0.8 laser procedures STANDARD_DEVIATION 1.1 • n=5 Participants	1.0 laser procedures STANDARD_DEVIATION 1.1 • n=7 Participants	0.9 laser procedures STANDARD_DEVIATION 1.1 • n=5 Participants
Prior Ocular Surgeries	1.8 Ocular Surgeries STANDARD_DEVIATION 1.3 • n=5 Participants	1.6 Ocular Surgeries STANDARD_DEVIATION 1.1 • n=7 Participants	1.7 Ocular Surgeries STANDARD_DEVIATION 1.2 • n=5 Participants
Mean logMAR (converted) Visual Acuity	1.3 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.3 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.3 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
Number of Participants With Surgical Failure (Composite Measure)	63 participants	40 participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
Intraocular Pressure (IOP)	16.6 mmHg Standard Deviation 5.9	13.6 mmHg Standard Deviation 5.0

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
Anti-glaucoma Medications	1.8 glaucoma medications Standard Deviation 1.5	1.2 glaucoma medications Standard Deviation 1.3

SECONDARY outcome

Timeframe: 5 years

Visual acuity (VA) was tested monocularly (one eye at a time) using the manifest refraction adjusted for optical infinity using a standard Snellen Visual Acuity chart at 20 feet. Normal vision, or 20/20 vision, means that the participant can see at 20 feet what a healthy control can also see at 20 feet. Legal blindness, or 20/200 vision, means the participant can see at 20 feet what a healthy control can see at 200 feet. Hence, an increasing denominator implies visual impairment. Counting fingers was designated as 20/2000 vision, hand motions was 20/16000, light perception was 20/32000 and no light perception was 20/64000. To allow for appropriate statistical analysis, logMAR Snellen Visual Acuity was calculated using the formula: -logMAR (Snellen Acuity). This means that normal vision (20/20) would correspond to a value of 0, legal blindness (20/200) would correspond to a value of 1, and no light perception (20/64000) would correspond to 3.5.

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
LogMAR Snellen Visual Acuity	1.6 logMAR units on a scale Standard Deviation 1.0	1.6 logMAR units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
Number of Participants With Complications During or After Surgery	78 Participants	79 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Ahmed Group n=124 Participants Ahmed FP7 Valve Implant	Baerveldt Group n=114 Participants Baerveldt-350 Implant
Number of Participants With Interventions After Surgery	64 Participants	58 Participants

Adverse Events

Ahmed Group

Serious events: 14 serious events

Other events: 78 other events

Deaths: 0 deaths

Baerveldt Group

Serious events: 19 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ahmed Group n=124 participants at risk Ahmed FP7 Valve Implant	Baerveldt Group n=114 participants at risk Baerveldt-350 Implant
Eye disorders Suprachoroidal Hemorrhage	1.6% 2/124 • Number of events 2	2.6% 3/114 • Number of events 3
Eye disorders Phthisis Bulbi	0.81% 1/124 • Number of events 1	1.8% 2/114 • Number of events 2
Eye disorders Retinal Detachment	0.81% 1/124 • Number of events 1	0.00% 0/114
Eye disorders Endophthalmitis	0.81% 1/124 • Number of events 1	0.00% 0/114
Eye disorders Progression to no light perception	5.6% 7/124 • Number of events 7	6.1% 7/114 • Number of events 7
Eye disorders Device Explantation	0.81% 1/124 • Number of events 1	1.8% 2/114 • Number of events 2
Eye disorders Evisceration or enucleation	2.4% 3/124 • Number of events 3	0.00% 0/114
Eye disorders Hypotony Requiring Additional Surgery	0.81% 1/124 • Number of events 1	5.3% 6/114 • Number of events 6
Eye disorders Aqueous misdirection	1.6% 2/124 • Number of events 2	3.5% 4/114 • Number of events 4

Other adverse events

Other adverse events
Measure	Ahmed Group n=124 participants at risk Ahmed FP7 Valve Implant	Baerveldt Group n=114 participants at risk Baerveldt-350 Implant
Eye disorders Shallow Anterior Chamber	14.5% 18/124 • Number of events 18	16.7% 19/114 • Number of events 19
Eye disorders Choroidal Effusions	12.9% 16/124 • Number of events 16	15.8% 18/114 • Number of events 18
Eye disorders Tube Complications	13.7% 17/124 • Number of events 17	16.7% 19/114 • Number of events 19
Eye disorders Corneal Edema	11.3% 14/124 • Number of events 14	12.3% 14/114 • Number of events 14
Eye disorders Iritis	7.3% 9/124 • Number of events 9	12.3% 14/114 • Number of events 14
Eye disorders Cataract Progression	32.4% 11/34 • Number of events 11	40.6% 13/32 • Number of events 13
Eye disorders Encapsulated Bleb	11.3% 14/124 • Number of events 14	3.5% 4/114 • Number of events 4
Eye disorders Hyphema	3.2% 4/124 • Number of events 4	5.3% 6/114 • Number of events 6
Eye disorders Motility Disorder	4.8% 6/124 • Number of events 6	1.8% 2/114 • Number of events 2
Eye disorders High IOP requiring surgery	15.3% 19/124 • Number of events 19	9.6% 11/114 • Number of events 11
Eye disorders Other	4.8% 6/124 • Number of events 6	6.1% 7/114 • Number of events 7

Additional Information

Dr. Iqbal Ike K. Ahmed

Prism Eye Institute

Phone: 905-456-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place