Expired Study
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Winston Salem, North Carolina 27157


Purpose:

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. 1. Cystoid macular edema is a common complication of uveitic intraocular inflammatory diseases and is characterized by intraretinal edema involving the outer plexiform layer. Intraocular inflammation or uveitis may be associated with non infectious or infectious etiologies. The early symptoms of CME include a decrease or blurry central vision. With long standing CME there is a substantial risk of photoreceptor degeneration and ensuing long term decrease in the quality and level of visual acuity (VA). Furthermore it has been shown that in patients with uveitis, the morphologic features of macular edema and macular thickness correlated with final VA. Current therapeutic interventions have had at best modest results in patients with CME who have had decreased VA. This may the case with systemic interventions also. 2. Vascular endothelial growth factor is a very strong inducer of blood vessel permeability and has been linked to the ocular manifestations of uveitis including CME by experienced researchers both in experimental and clinical settings. In animal tests, VEGF has been shown to be 50,000 times more potent than histamine, the molecule commonly associated with blood vessel leakage related to allergies. Also in animal tests, it has been shown that VEGF is required for the blood vessel permeability associated with neovascular AMD and diabetic retinopathy that have been shown to have an inflammatory component. In addition to its anti-angiogenic property of inhibiting abnormal blood vessel growth, pegaptanib has been shown in animal tests to inhibit blood vessels from leaking into the retina. Uveitis has been shown to be associated with ocular neovascularization both clinically and well as in the clinical studies. Thus, by preventing blood vessel leakage as well as abnormal blood vessel growth pegaptanib may be a viable approach for the treatment of CME. Although pegaptanib use has been associated with mild transient anterior segment inflammation CME itself has not been linked to its use. Besides, pegaptanib has been demonstrated to effect a sustainable decrease the macular edema in maculopathies, both age related and diabetic. 3. There is currently a need for considering alternative forms of local (ocular) therapy for CME to triamcinolone (sub tenon and intraocular). The serious adverse effects with intraocular corticosteroid use are well documented and include cataracts (nuclear and subcapsular), glaucoma, endophthalmitis (may be significantly higher than pegaptanib in patients who are treated exactly as per protocol) as well as sterile inflammatory reactions.


Criteria:

Inclusion Criteria: 1. Male and female adults (>18 years of age) with non infectious uveitis. 2. Demonstrable (FA and/or OCT) bilateral or unilateral CME associated with uveitis of greater than 3 months but less than 1 years duration that is documented by two independent qualified observers. 3. Best corrected VA between 20/40 and 20/200 as measured by the ETDRS chart attributable to CME in the study eye. 4. Patients may be receiving systemic therapy for the treatment of their intraocular inflammation or cystoid macular edema, or may have been treated for the cystoid macular edema in the past. 5. Anterior chamber inflammation equal to or greater than 1+ and vitreous inflammation equal to or greater than 1+ cell and 1+ haze as per the 'Standardization of Uveitis' working group definition. 6. Females of child bearing potential must agree to utilize effective contraception during the study and two months after the last dose of study medication. 7. Male study patients will agree to use effective contraception. 8. Ability to give informed consent. Exclusion Criteria: 1. Allergy to pegaptanib or any of its components 2. Diabetic retinopathy, macular degeneration or any other ocular condition affecting the study eye that may cause vision loss or in the opinion of the study investigator would interfere with the evaluation of the efficacy of Macugen for the treatment of uveitis associated CME. 3. Refusal to try the therapeutic alternative pegaptanib 4. Lack of understanding of the consent or protocol 5. Suspicion/proved history or current diagnosis, (clinical or otherwise) of infectious uveitis. 6. Need for intraocular surgery within 30 weeks of study duration. 7. Periocular steroids to the study eye less than 6 weeks prior to study enrollment 8. History of any prior intravitreal injections in study eye 9. Systemic immunomodulatory agent(s) added or increased in dosage (>20%) within the last two months prior to study enrollment, or potential need for any increase during the study. 10. Requirement for systemic corticosteroids in the equivalent of oral prednisone > 30mg/day 11. Topical prostaglandin analog use 12. Severe debilitating disease or medical problems that make consistent follow-up over the treatment period unlikely (e.g. liver impairment, stroke, severe myocardial infarction, terminal cancer). 13. History of hypersensitivity to fluorescein or multiple drug allergies that may increase the chance of a drug reaction to Macugen. 14. Unclear media that precludes assessment of cystoid macular edema in eligible eye(s), such as a cataract or vitreal opacity. 15. Evidence of a macular hole in the study eye. 16. Prior or current retinal detachment in the study eye. 17. Concurrent treatment with any new investigational drug. 18. Pregnant or lactating women (Pregnant and lactating women are excluded since pregnancy may have some effect on CME). 19. Inability to comply with the study requirements.


Study is Available At:


Original ID:

4499 Pegaptanib in uveiti


NCT ID:

NCT00790803


Secondary ID:


Study Acronym:


Brief Title:

Pegaptanib Therapy in Uveitis


Official Title:

Evaluation of the Utility of Intravitreal Vascular Endothelial Growth Factor (VEGF) Blockade With Pegaptanib in Cystoid Macular Edema (CME) Associated With Non Infectious Intermediate and Panuveitis in an Open Label, Non Randomized, Uncontrolled Intervent


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Actual


Overall Contact Information

Official Name:Shree Kurup, MD
Principal Investigator
Wake Forest University Eye Center

Study Dates

Start Date:March 2009
Primary Completion Date:November 2011
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 18, 2012
First Received Date:November 12, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in immunomodulatory medications (topical, periocular or systemic) after the initiation of Macugen therapy
Time Frame:32 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:A change in anterior chamber cells or vitreous cells or haze in injected eye
Time Frame:32 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Decrease in CME as evidenced by imaging (fluorescein angiography and 50 micron change in OCT)
Time Frame:32 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of patients experiencing > 0 letter vision gain and a < 15 loss
Time Frame:32 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Improvement in VA ETDRS >/= 15 letters
Time Frame:32 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pegaptanib (Macugen)
Description:Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Arm Name:Macugen

Study Arms

Study Arm Type:Other
Arm Name:Macugen
Description:Single arm pilot trial

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:15019324
Reference Type:Reference
Citation:Okhravi N, Lightman S. Cystoid macular edema in uveitis. Ocul Immunol Inflamm. 2003 Mar;11(1):29-38. Review.
PMID:12854025
Reference Type:Reference
Citation:Kurup SK, Chan CC. Immunotherapeutic approaches in ocular inflammatory diseases. Arch Immunol Ther Exp (Warsz). 2005 Nov-Dec;53(6):484-96. Review.
PMID:16407781
Reference Type:Reference
Citation: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.
PMID:9726824
Reference Type:Reference
Citation:Kurup SK, Chan CC. Mycobacterium-related ocular inflammatory disease: diagnosis and management. Ann Acad Med Singapore. 2006 Mar;35(3):203-9.
PMID:16625271
Reference Type:Reference
Citation:Rothova A. Medical treatment of cystoid macular edema. Ocul Immunol Inflamm. 2002 Dec;10(4):239-46. Review.
PMID:12854032
Reference Type:Reference
Citation: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.
PMID:15121373
Reference Type:Reference
Citation: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.
PMID:11704050
Reference Type:Reference
Citation: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. No abstract available.
PMID:16769855
Reference Type:Reference
Citation: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. Review.
PMID:16490578
Reference Type:Reference
Citation: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.
PMID:16154196
Reference Type:Reference
Citation:D'Amico DJ; VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group; 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):1001.e1-6. Epub 2006 Apr 27.
PMID:16647134
Reference Type:Reference
Citation: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.
PMID:16019686
Reference Type:Reference
Citation:Konstantopoulos A, Williams CP, Newsom RS, Luff AJ. Ocular morbidity associated with intravitreal triamcinolone acetonide. Eye. 2007 Mar;21(3):317-20. Epub 2006 May 19.
PMID:16710433

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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