Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema
|ClinicalTrials.gov Identifier: NCT00790803|
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : September 26, 2013
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uveitis Cystoid Macular Edema||Drug: Pegaptanib||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vascular Endothelial Growth Factor (VEGF)Blockade With Intravitreal Pegaptnib in Non-Infectious Uveitic Cystoid Macular Edema (CME)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||March 2012|
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
- Improvement in VA ETDRS >/= 15 Letters [ Time Frame: 32 weeks ]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 ]Patients best corrected visual acuity was 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 ]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 ]
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:
- 0 - None.
- 1+ - faint (barely detectable).
- 2+ - moderate (clear iris and lens details).
- 3+ - moderate (hazy iris and lens details).
- 4+ - intense (fibrin deposits, coagulated aqueous).
- Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy [ Time Frame: 32 weeks ]No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|