Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vascular Endothelial Growth Factor (VEGF)Blockade With Intravitreal Pegaptnib in Non-Infectious Uveitic Cystoid Macular Edema (CME)|
- Improvement in VA ETDRS >/= 15 Letters [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.
- Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]Patients best corrected visual acuity will be measured at each visit to monitor gain or loss of letters on the EDTRS chart.
- Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.
- A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.
- Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.
|Study Start Date:||March 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Open label, non randomized, interventional controlled injection of 0.3mg of Pegaptanib (Macugen) every 6weeks with max of 5 injections over 30weeks.
Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Other Name: Macugen
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790803
|United States, North Carolina|
|Wake Forest University Eye Center|
|Winston Salem, North Carolina, United States, 27157|
|Principal Investigator:||Shree Kurup, MD||Wake Forest University Eye Center|