Glaucoma Clinical Trial
— NVGOfficial title:
Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma
Verified date | July 2008 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 15, 2009 |
Est. primary completion date | May 15, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age > 21 years - Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye). - Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.) Exclusion Criteria: - Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. - Prior enrollment in the study - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated - Participation in another simultaneous medical investigation or trial - > 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae) - History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures. - Previous intravitreal injections of ranibizumab or bevacizumab in either eye. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Illinois at Chicago | Genentech, Inc. |
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. — View Citation
Davidorf FH, Mouser JG, Derick RJ. Rapid improvement of rubeosis iridis from a single bevacizumab (Avastin) injection. Retina. 2006 Mar;26(3):354-6. — View Citation
Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004 Aug;25(4):581-611. Review. — View Citation
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. Epub 2006 Jul 19. — View Citation
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. Epub 2006 Aug 2. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | ||
Secondary | Percent change in angle neovascularization (measured in clock hours by gonioscopy). | Initial visit through Month 6 | ||
Secondary | Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy). | Initial visit through Month 6 | ||
Secondary | Mean change in intraocular pressure measured by applanation tonometry. | Initial visit through Month 6 | ||
Secondary | Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography). | Initial visit through Month 6 | ||
Secondary | Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart). | Initial Visit through Month 6 | ||
Secondary | Number of intraocular pressure lowering medications needed to control intraocular pressure. | Initial Visit through Month 6 | ||
Secondary | Mean change in optic nerve cupping. | Initial Visit through Month 6 | ||
Secondary | Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction). | Study duration | ||
Secondary | Percent of patients requiring pars plana vitrectomy with endolaser. | Study duration | ||
Secondary | Rates of endophthalmitis. | Study duration | ||
Secondary | Rates of rhegmatogenous retinal detachment. | Study duration | ||
Secondary | Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy) | Month 6 visit |
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