Avastin: Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

• Sponsor: Wills Eye (Other)
• Overall Status: Completed
• CT.gov ID: NCT00853073
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: bevacizumab; Other: balanced salt solution	Phase 2/Phase 3

Detailed Description

To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bevacizumab subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Drug: bevacizumab; 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure; Other Names: Avastin
Placebo Comparator: balanced salt solution patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Other: balanced salt solution; 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) [6 months]

   mmHg (millimeters of mercury)

Secondary Outcome Measures

1. Number of Participants With Surgical Success [6 months]

   Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• require glaucoma bleb needle revision with Mitomycin-C

Exclusion Criteria:

• pregnant, nursing, or not using adequate contraception

• other glaucoma eye surgery involving tube shunts

• prior retinal detachments surgery with scleral buckle

• infection, inflammation, or any abnormality preventing eye pressure measurement

• enrolled in another investigational study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Institute, Glaucoma Service	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Wills Eye

Investigators

• Principal Investigator: Marlene R Moster, MD, Wills Eye

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marlene Moster, MD, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT00853073
• Other Study ID Numbers: 08-867
• First Posted: Feb 27, 2009
• Last Update Posted: Jul 9, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Marlene Moster, MD, Principal Investigator, Wills Eye: failing blebs; failing express shunt; avastin; bevacizumab; glaucoma; prior trabeculectomy; Express shunt placed under a scleral flap; subsequent filtration failure
• Additional relevant MeSH terms: Glaucoma; Bevacizumab

Study Results

Participant Flow

Recruitment Details	Eligible patients were recruited between February 2009 and July 2011 from the Glaucoma Service located at Wills Eye Hospital in Philadelphia.

Arm/Group Title	Treatment A (Bevacizumab)	Treatment B (Balanced Salt Solution)
Arm/Group Description	patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Period Title: Overall Study
STARTED	32	31
COMPLETED	29	29
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Treatment A (Bevacizumab)	Treatment B (Balanced Salt Solution)	Total
Arm/Group Description	patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	Total of all reporting groups
Overall Participants	29	29	58
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64.6	71.2	67.9
Sex: Female, Male (Count of Participants)
Female	11 37.9%	12 41.4%	23 39.7%
Male	18 62.1%	17 58.6%	35 60.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 6.9%	0 0%	2 3.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 41.4%	15 51.7%	27 46.6%
White	15 51.7%	14 48.3%	29 50%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%	29 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP)
Description	mmHg (millimeters of mercury)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment A (Bevacizumab)	Treatment B (Balanced Salt Solution)
Arm/Group Description	patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Measure Participants	29	29
Mean (95% Confidence Interval) [mmHg (millimeters of mercury)]	11.52	12.83

2. Secondary Outcome

Title	Number of Participants With Surgical Success
Description	Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment A (Bevacizumab)	Treatment B (Balanced Salt Solution)
Arm/Group Description	patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.	patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Measure Participants	29	29
Complete success	17 58.6%	12 41.4%
Qualified success	0 0%	2 6.9%
Failure	12 41.4%	15 51.7%

Adverse Events

Adverse Event Reporting Description	At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
Arm/Group Title	Treatment A (Bevacizumab)		Treatment B (Balanced Salt Solution)
Arm/Group Description	patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.		patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
All Cause Mortality
	Treatment A (Bevacizumab)		Treatment B (Balanced Salt Solution)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Treatment A (Bevacizumab)		Treatment B (Balanced Salt Solution)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A (Bevacizumab)		Treatment B (Balanced Salt Solution)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/29 (58.6%)		15/29 (51.7%)
Eye disorders
Hyphema	4/29 (13.8%)	4	3/29 (10.3%)	3
Shallow Anterior Chamber	7/29 (24.1%)	7	5/29 (17.2%)	5
Shallow Anterior Chamber necessitating injection of viscoelastic	1/29 (3.4%)	1	1/29 (3.4%)	1
Endothelial folds	4/29 (13.8%)	4	4/29 (13.8%)	4
Retinal/Choroidal folds	5/29 (17.2%)	5	5/29 (17.2%)	5
Choroidals	6/29 (20.7%)	6	1/29 (3.4%)	1

Limitations/Caveats

Small sample size which did not allow further subgroup analysis based on these patient characteristics.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.