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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery |
|
| 2 | Active Comparator | 20 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | sub-conjunctival injection of 1.25mg Bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleb vascularity grading | 1, 2, 3, 4, 5. 6. montes post operative. |
| Measure | Description | Time Frame |
|---|---|---|
| Indiana Bleb Appearance Grading Scale (IBAGS) | 1, 2, 3, 4, 5, 6 months post operative | |
| Intra-ocular pressure | 1, 2, 3, 4, 5, 6 months post operative | |
| Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| moshe lusky, MD | Contact | 972-39376113 | moshel@clalit.org.il | |
| omer Y bialer, MD | Contact | 972-39376100 | omerb2@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| moshe lusky, MD | Rabin Medical Center | Principal Investigator |
| omer Y bialer, MD | rabin medial center | Study Chair |
| anat robinson, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18026201 | Background | 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. | |
| 9932993 | Result | Schwartz 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. |
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| ID | Term |
|---|---|
| D001768 | Blister |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 1, 2, 3, 4, 5, 6 months post operative |
| Rabin Medical Center |
| Study Chair |
| 18692246 | Result | Grewal 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. |
| 18854726 | Result | Coote 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. |
| 16583638 | Result | Kahook 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. |
| Result | Treatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |