Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema

NCT00790803 | Completed Results

• 1 other identifier: 4499 Pegaptanib in uveitis
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveitis; Cystoid Macular Edema

Keywords

uveitis; cystoid macular edema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss

  32 weeks

• Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)

  32 weeks

• A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye

  32 weeks

• Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy

  32 weeks

Study Arms (1)

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.

Drug: Pegaptanib

Interventions

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.

Also known as: Macugen

Pegaptanib (Macugen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (\>18 years of age) with non infectious uveitis.
• 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.
• Best corrected VA between 20/40 and 20/200 as measured by the ETDRS chart attributable to CME in the study eye.
• 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.
• 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.
• Females of child bearing potential must agree to utilize effective contraception during the study and two months after the last dose of study medication.
• Male study patients will agree to use effective contraception.
• Ability to give informed consent.

You may not qualify if:

• Allergy to pegaptanib or any of its components
• 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.
• Refusal to try the therapeutic alternative pegaptanib
• Lack of understanding of the consent or protocol
• Suspicion/proved history or current diagnosis, (clinical or otherwise) of infectious uveitis.
• Need for intraocular surgery within 30 weeks of study duration.
• Periocular steroids to the study eye less than 6 weeks prior to study enrollment
• History of any prior intravitreal injections in study eye
• 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.
• Requirement for systemic corticosteroids in the equivalent of oral prednisone \> 30mg/day
• Topical prostaglandin analog use
• 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).
• History of hypersensitivity to fluorescein or multiple drug allergies that may increase the chance of a drug reaction to Macugen.
• Unclear media that precludes assessment of cystoid macular edema in eligible eye(s), such as a cataract or vitreal opacity.
• Evidence of a macular hole in the study eye.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Eye Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (14)

• 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.

  PMID: 15019324 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.

  PMID: 12854025 BACKGROUND

• Kurup SK, Chan CC. Immunotherapeutic approaches in ocular inflammatory diseases. Arch Immunol Ther Exp (Warsz). 2005 Nov-Dec;53(6):484-96.

  PMID: 16407781 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.

  PMID: 9726824 BACKGROUND

• Kurup SK, Chan CC. Mycobacterium-related ocular inflammatory disease: diagnosis and management. Ann Acad Med Singap. 2006 Mar;35(3):203-9.

  PMID: 16625271 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.

  PMID: 12854032 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.

  PMID: 15121373 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.

  PMID: 11704050 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.

  PMID: 16769855 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.

  PMID: 16490578 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.

  PMID: 16154196 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.

  PMID: 16647134 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.

  PMID: 16019686 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.

  PMID: 16710433 BACKGROUND

MeSH Terms

Conditions

Uveitis; Macular Edema

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Limitations and Caveats

Implementing screening protocols to catch less progressed CME cases could improve outcomes.

Results Point of Contact

• Title: Dr. Shree Kurup
• Organization: Wake Forest Baptist Health Eye Center

skk@retinacenterspc.com

336-716-4091

Study Officials

• Shree Kurup, MD

  Wake Forest University Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: March 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 15, 2022
• Results First Posted: September 26, 2013

Record last verified: 2017-02

Locations

US (1)