A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

You may not qualify if:

• Cannot attened all trail required visits
• Eyes in which retinal surgery is needed now are is likely to be needed within 6 months, which the surgeon believes will not respond to non-surgical intervention.
• Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion greater than 1 disc area involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula.
• Vitreomacular traction determined clinically and/or by OCT, which, in the investigator's opinion, contributes to the macular edema, or causes associated foveal detachment, and would preclude improvement with pegaptanib sodium.
• Previous treatment with intravitreal corticosteroids in the study eye within 3 months of Day 0 visit.
• Previous treatment with intravitreal anti-angiogenic drugs in the study eye within 2 months of Day 0 visit.
• Previous intraocular surgery within 30 days of Day 0 visit.
• Any ocular or periocular infection within 30 days of Day 0 visit.
• Any of the following underlying diseases including:
• History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment.
• History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
• History or evidence of clinically significant impaired renal or hepatic function Stroke (within 12 months of trial entry). Any major surgical procedure within one month of trial entry.
• Any treatment with an investigational agent in the past 30 days for any condition.
• Known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation.