GlaucomaPhase 2/3AvastinNCT00853073

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

A Phase 2/3 study testing bevacizumab and balanced salt solution in people with Glaucoma, run by Wills Eye at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma
What is being tested?: bevacizumab and balanced salt solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Jan 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

require glaucoma bleb needle revision with Mitomycin-C

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wills Eye Institute, Glaucoma Service
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?

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.

Read the 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.

Conditions: Glaucoma
Being tested: bevacizumab, balanced salt solution
Keywords: failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bevacizumabDrug
Also called Avastin
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
balanced salt solutionOther
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Study groups in NCT00853073
Study group	Role	What they receive
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. Receives: 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. Receives: Other: balanced salt solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP)
mmHg (millimeters of mercury)
Measured: 6 months

Secondary outcomes (1)

Number of Participants With Surgical Success
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jan 2012

First posted27 Feb 2009 (estimated)
Study startFeb 2009
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853073
Sponsor's protocol ID: 08-867
Acronym: Avastin
Status last verified: Jun 2018
First submitted: 26 Feb 2009
Last updated: 9 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25826644

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
ClinicalTrials.gov ID: NCT00853073
Acronym / sponsor ID: Avastin / 08-867
Conditions: Glaucoma
Keywords: failing blebs, failing express shunt, avastin, bevacizumab, glaucoma, prior trabeculectomy, Express shunt placed under a scleral flap, subsequent filtration failure
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Study start: Feb 2009
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 27 Feb 2009 (estimated)
Results: Posted 12 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bevacizumab	Active comparator	Drug: bevacizumabsubjects 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.
balanced salt solution	Placebo comparator	Other: balanced salt solutionpatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

require glaucoma bleb needle revision with Mitomycin-C

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bevacizumabAlso: Avastin1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure	Drug	Bevacizumab
balanced salt solution0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure	Other	balanced salt solution

Primary outcome

Intraocular Pressure (IOP)
Time frame: 6 months
mmHg (millimeters of mercury)

1 secondary outcome

Number of Participants With Surgical Success
Time frame: 6 months

Results and safety

Results posted to the registry on 12 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A (Bevacizumab)	32	29
Treatment B (Balanced Salt Solution)	31	29

Primary outcome: Intraocular Pressure (IOP)

Time frame: 6 months. Mean (95% Confidence Interval). Unit: mmHg (millimeters of mercury)

Measure	Treatment A (Bevacizumab) n = 29	Treatment B (Balanced Salt Solution) n = 29
Value	11.52 (9.44 to 14.05)	12.83 (10.44 to 15.77)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A (Bevacizumab)	0 of 29 (0%)	17 of 29 (58.6%)	0 of 29
Treatment B (Balanced Salt Solution)	0 of 29 (0%)	15 of 29 (51.7%)	0 of 29

Limitations and caveats (from the sponsor): Small sample size which did not allow further subgroup analysis based on these patient characteristics.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25826644Tai 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.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marlene R Moster, MD principal investigator

Wills Eye

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing bevacizumab and balanced salt solution in people with Glaucoma, run by Wills Eye at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (IOP) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.