Bleb VascularityPhase 2NCT00854529
Subconjunctival Bevacizumab Effect on Bleb Vascularity
A Phase 2 study testing Bevacizumab in people with Bleb Vascularity and Bleb Fibrosis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- post uneventful trabeculectomy with mitomycin c application during surgery
- adult
Who cannot join
- usage of 5-fluorouracil in trabeculectomy
- post-operative complications
- ischemic heart disease
- s/p cerebrovascular accident
- allergy to bevacizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
Read the detailed description
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
- Conditions
- Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
sub-conjunctival injection of 1.25mg Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery Receives: Drug: Bevacizumab |
| 2 | Active comparator | 20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery Receives: Drug: Bevacizumab |
| 3 | No intervention | 20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleb vascularity grading
Measured: 1, 2, 3, 4, 5. 6. montes post operative.
Secondary outcomes (3)
Indiana Bleb Appearance Grading Scale (IBAGS)
Measured: 1, 2, 3, 4, 5, 6 months post operative
Intra-ocular pressure
Measured: 1, 2, 3, 4, 5, 6 months post operative
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Measured: 1, 2, 3, 4, 5, 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bleb VascularityStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- moshe lusky, MD, Principal investigator, Rabin Medical Centeromer Y bialer, MD, Study chair, rabin medial centeranat robinson, MD, Study chair, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854529
- Sponsor's protocol ID
- 005285
- Status last verified
- Feb 2009
- First submitted
- 1 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. doi: 10.3129/i07-160.
PubMed 18026201Schwartz AL, Van Veldhuisen PC, Gaasterland DE, Ederer F, Sullivan EK, Cyrlin MN. The Advanced Glaucoma Intervention Study (AGIS): 5. Encapsulated bleb after initial trabeculectomy. Am J Ophthalmol. 1999 Jan;127(1):8-19. doi: 10.1016/s0002-9394(98)00290-6.
PubMed 9932993Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.
PubMed 18692246Coote MA, Ruddle JB, Qin Q, Crowston JG. Vascular changes after intra-bleb injection of bevacizumab. J Glaucoma. 2008 Oct-Nov;17(7):517-8. doi: 10.1097/IJG.0b013e31815f5345.
PubMed 18854726Kahook MY, Schuman JS, Noecker RJ. Needle bleb revision of encapsulated filtering bleb with bevacizumab. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):148-50.
PubMed 16583638Treatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
- ClinicalTrials.gov ID
- NCT00854529
- Acronym / sponsor ID
- 005285
- Conditions
- Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure
- Keywords
- bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
Detailed description
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bevacizumab20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery |
| 2 | Active comparator | Drug: Bevacizumab20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery |
| 3 | No intervention | –20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post uneventful trabeculectomy with mitomycin c application during surgery
- adult
Key exclusion criteria (5 listed)
- usage of 5-fluorouracil in trabeculectomy
- post-operative complications
- ischemic heart disease
- s/p cerebrovascular accident
- allergy to bevacizumab
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: Avastinsub-conjunctival injection of 1.25mg Bevacizumab | Drug | 1, 2 |
Primary outcome
Bleb vascularity grading
Time frame: 1, 2, 3, 4, 5. 6. montes post operative.
3 secondary outcomes
Indiana Bleb Appearance Grading Scale (IBAGS)
Time frame: 1, 2, 3, 4, 5, 6 months post operative
Intra-ocular pressure
Time frame: 1, 2, 3, 4, 5, 6 months post operative
Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Time frame: 1, 2, 3, 4, 5, 6 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
- Background: PubMed 18026201Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. doi: 10.3129/i07-160.
- Results publication: PubMed 9932993Schwartz AL, Van Veldhuisen PC, Gaasterland DE, Ederer F, Sullivan EK, Cyrlin MN. The Advanced Glaucoma Intervention Study (AGIS): 5. Encapsulated bleb after initial trabeculectomy. Am J Ophthalmol. 1999 Jan;127(1):8-19. doi: 10.1016/s0002-9394(98)00290-6.
- Results publication: PubMed 18692246Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.
- Results publication: PubMed 18854726Coote MA, Ruddle JB, Qin Q, Crowston JG. Vascular changes after intra-bleb injection of bevacizumab. J Glaucoma. 2008 Oct-Nov;17(7):517-8. doi: 10.1097/IJG.0b013e31815f5345.
- Results publication: PubMed 16583638Kahook MY, Schuman JS, Noecker RJ. Needle bleb revision of encapsulated filtering bleb with bevacizumab. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):148-50.
- Results publicationTreatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov
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.
moshe lusky, MD principal investigator
Rabin Medical Center
omer Y bialer, MD study chair
rabin medial center
anat robinson, MD study chair
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Bleb Vascularity and Bleb Fibrosis, run by Rabin Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact moshe lusky, MD (972-39376113, moshel@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleb vascularity grading (time frame: 1, 2, 3, 4, 5. 6. montes post operative.). 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 NCT00854529, which also lists 6 linked publications.
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 3 Mar 2009.