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

NCT00853073 | Completed Phase 2 Results

• 1 other identifier: 08-867
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

failing blebs; failing express shunt; avastin; bevacizumab; glaucoma; prior trabeculectomy; Express shunt placed under a scleral flap; subsequent filtration failure

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  mmHg (millimeters of mercury)

  6 months

Secondary Outcomes (1)

• Number of Participants With Surgical Success

  6 months

Study Arms (2)

Bevacizumab

ACTIVE COMPARATOR

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

balanced salt solution

PLACEBO COMPARATOR

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

Interventions

bevacizumab DRUG

1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure

Also known as: Avastin

Bevacizumab

balanced salt solution OTHER

0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

balanced salt solution

Eligibility Criteria

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

You may qualify if:

• require glaucoma bleb needle revision with Mitomycin-C

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Tai TY, Moster MR, Pro MJ, Myers JS, Katz LJ. Needle bleb revision with bevacizumab and mitomycin C compared with mitomycin C alone for failing filtration blebs. J Glaucoma. 2015 Apr-May;24(4):311-5. doi: 10.1097/IJG.0b013e31829f9bd3.

  PMID: 25826644 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Bevacizumab; Hanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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

Results Point of Contact

• Title: Marlene R. Moster, MD
• Organization: Wills Eye Hospital

marlenemoster@gmail.com

215-928-3123

Study Officials

• Marlene R Moster, MD

  Wills Eye

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 9, 2018
• Results First Posted: March 12, 2015

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)