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According to a recent estimate more than 280,000 people in the United States are affected by uveitis each year. This report, also estimated that uveitis is the reason for 30,000 new cases of blindness/year and up to 10 percent of all cases of blindness. The purpose of this trial is to determine the effectiveness of VEGF blockade with intravitreal pegaptanib in patients with uveitic CME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegaptanib (Macugen) | Other | Open label, non randomized, interventional controlled injection of 0.3mg of Pegaptanib (Macugen) every 6weeks with max of 5 injections over 30weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaptanib | Drug | Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in VA ETDRS >/= 15 Letters | The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss | Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart. | 32 weeks |
| Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shree Kurup, MD | Wake Forest University Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Eye Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15019324 | Background | Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014. | |
| 12854025 | Background | Okhravi N, Lightman S. Cystoid macular edema in uveitis. Ocul Immunol Inflamm. 2003 Mar;11(1):29-38. doi: 10.1076/ocii.11.1.29.15582. |
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Five consecutive adult patients with non-infectious uveitis associated CME were chosen for this study. Only patients with a baseline best corrected VA between 20/40 and 20/200, attributable to CME, were selected for the study. In qualified patients with bilateral disease, the eye with the worse visual acuity was selected for the study eye.
Five patients with non-infectious uveitis, ongoing for greater than three months but less than twelve months with associated CME. Patients were identified in the PI's regular medical clinic and received five intravitreal pegaptanib doses over the course of thirty weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Macugen | Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macugen | Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement in VA ETDRS >/= 15 Letters | The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart. | Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve. | Posted | Number | participants | 32 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macugen | Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five. |
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Implementing screening protocols to catch less progressed CME cases could improve outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shree Kurup | Wake Forest Baptist Health Eye Center | 336-716-4091 | skk@retinacenterspc.com |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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|
Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness. |
| 32 weeks |
| A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye | The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye. In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare. White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body. Blood cells: grading of blood cells in the anterior chamber is as follows:
| 32 weeks |
| Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy | No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy. | 32 weeks |
| 16407781 | Background | Kurup SK, Chan CC. Immunotherapeutic approaches in ocular inflammatory diseases. Arch Immunol Ther Exp (Warsz). 2005 Nov-Dec;53(6):484-96. |
| 9726824 | Background | Vinores SA, Chan CC, Vinores MA, Matteson DM, Chen YS, Klein DA, Shi A, Ozaki H, Campochiaro PA. Increased vascular endothelial growth factor (VEGF) and transforming growth factor beta (TGFbeta) in experimental autoimmune uveoretinitis: upregulation of VEGF without neovascularization. J Neuroimmunol. 1998 Aug 14;89(1-2):43-50. doi: 10.1016/s0165-5728(98)00075-7. |
| 16625271 | Background | Kurup SK, Chan CC. Mycobacterium-related ocular inflammatory disease: diagnosis and management. Ann Acad Med Singap. 2006 Mar;35(3):203-9. |
| 12854032 | Background | Rothova A. Medical treatment of cystoid macular edema. Ocul Immunol Inflamm. 2002 Dec;10(4):239-46. doi: 10.1076/ocii.10.4.239.15589. |
| 15121373 | Background | Markomichelakis NN, Halkiadakis I, Pantelia E, Peponis V, Patelis A, Theodossiadis P, Theodossiadis G. Patterns of macular edema in patients with uveitis: qualitative and quantitative assessment using optical coherence tomography. Ophthalmology. 2004 May;111(5):946-53. doi: 10.1016/j.ophtha.2003.08.037. |
| 11704050 | Background | Fine HF, Baffi J, Reed GF, Csaky KG, Nussenblatt RB. Aqueous humor and plasma vascular endothelial growth factor in uveitis-associated cystoid macular edema. Am J Ophthalmol. 2001 Nov;132(5):794-6. doi: 10.1016/s0002-9394(01)01103-5. |
| 16769855 | Background | Krzystolik MG, Filippopoulos T, Ducharme JF, Loewenstein JI. Pegaptanib as an adjunctive treatment for complicated neovascular diabetic retinopathy. Arch Ophthalmol. 2006 Jun;124(6):920-1. doi: 10.1001/archopht.124.6.920. No abstract available. |
| 16490578 | Background | Kourlas H, Schiller DS. Pegaptanib sodium for the treatment of neovascular age-related macular degeneration: a review. Clin Ther. 2006 Jan;28(1):36-44. doi: 10.1016/j.clinthera.2006.01.009. |
| 16154196 | Background | Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD; Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57. doi: 10.1016/j.ophtha.2005.06.007. |
| 16647134 | Background | VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group; D'Amico DJ, Masonson HN, Patel M, Adamis AP, Cunningham ET Jr, Guyer DR, Katz B. Pegaptanib sodium for neovascular age-related macular degeneration: two-year safety results of the two prospective, multicenter, controlled clinical trials. Ophthalmology. 2006 Jun;113(6):992-1001.e6. doi: 10.1016/j.ophtha.2006.02.027. Epub 2006 Apr 27. |
| 16019686 | Background | Amato JE, Lee DH, Santos BA, Akduman L. Steroid hypopyon following intravitreal triamcinolone acetonide injection in a pseudophakic patient. Ocul Immunol Inflamm. 2005 Apr-Jun;13(2-3):245-7. doi: 10.1080/09273940590928562. |
| 16710433 | Background | Konstantopoulos A, Williams CP, Newsom RS, Luff AJ. Ocular morbidity associated with intravitreal triamcinolone acetonide. Eye (Lond). 2007 Mar;21(3):317-20. doi: 10.1038/sj.eye.6702416. Epub 2006 May 19. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss | Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart. | Posted | Number | paticipants | 32 weeks |
|
|
|
| Secondary | Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT) | Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness. | Posted | Number | participants | 32 weeks |
|
|
|
| Secondary | A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye | The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye. In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare. White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body. Blood cells: grading of blood cells in the anterior chamber is as follows:
| Posted | Number | participants | 32 weeks |
|
|
|
| Secondary | Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy | No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy. | Posted | Number | participants | 32 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
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| D012164 |
| Retinal Diseases |