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| ID | Type | Description | Link |
|---|---|---|---|
| FVF4143S | Other Identifier | Genentech, Inc. |
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Company withdrew funding/sponsorship
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.
Hypothesis:
Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.
Specific Aims:
To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.
Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.
Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure.
Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lucentis (ranibizumab) with conventional treatment |
|
| 2 | No Intervention | Conventional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab (Lucentis) | Drug | 0.5 mg ranibizumab intravitreal injection single dose administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6. | Baseline to Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in angle neovascularization (measured in clock hours by gonioscopy). | Initial visit through Month 6 | |
| Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy). | Initial visit through Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Blair, MD | University of Illinois at Chicago | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16508438 | Background | Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available. | |
| 16508439 | Background | Davidorf FH, Mouser JG, Derick RJ. Rapid improvement of rubeosis iridis from a single bevacizumab (Avastin) injection. Retina. 2006 Mar;26(3):354-6. doi: 10.1097/00006982-200603000-00017. No abstract available. |
| Label | URL |
|---|---|
| University of Illinois at Chicago Eye and Ear Infirmary homepage | View source |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D015355 | Glaucoma, Neovascular |
| D012170 | Retinal Vein Occlusion |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Mean change in intraocular pressure measured by applanation tonometry. | Initial visit through Month 6 |
| Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography). | Initial visit through Month 6 |
| Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart). | Initial Visit through Month 6 |
| Number of intraocular pressure lowering medications needed to control intraocular pressure. | Initial Visit through Month 6 |
| Mean change in optic nerve cupping. | Initial Visit through Month 6 |
| Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction). | Study duration |
| Percent of patients requiring pars plana vitrectomy with endolaser. | Study duration |
| Rates of endophthalmitis. | Study duration |
| Rates of rhegmatogenous retinal detachment. | Study duration |
| Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy) | Month 6 visit |
| 15294883 | Background | Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004 Aug;25(4):581-611. doi: 10.1210/er.2003-0027. |
| 16854824 | Background | Fung AE, Rosenfeld PJ, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006 Nov;90(11):1344-9. doi: 10.1136/bjo.2006.099598. Epub 2006 Jul 19. |
| 17157590 | Background | Iliev ME, Domig D, Wolf-Schnurrbursch U, Wolf S, Sarra GM. Intravitreal bevacizumab (Avastin) in the treatment of neovascular glaucoma. Am J Ophthalmol. 2006 Dec;142(6):1054-6. doi: 10.1016/j.ajo.2006.06.066. Epub 2006 Aug 2. |
| 16583637 | Background | Kahook MY, Schuman JS, Noecker RJ. Intravitreal bevacizumab in a patient with neovascular glaucoma. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):144-6. |
| 11581047 | Background | Sivak-Callcott JA, O'Day DM, Gass JD, Tsai JC. Evidence-based recommendations for the diagnosis and treatment of neovascular glaucoma. Ophthalmology. 2001 Oct;108(10):1767-76; quiz1777, 1800. doi: 10.1016/s0161-6420(01)00775-8. |
| 7487614 | Background | Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96. |
| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |