Diabetic Macular Edema (DME) MedDRA version: 8.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Interventions
Trade Name: Macugen
Product Code: EYE001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib Sodium
CAS Number: 222716-86-1
Current Sponsor code: EYE001
Concentration unit: mg
Sponsors
Pfizer Inc 235 East 42nd Street New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: OPHTHALMIC CRITERIA Subjects must have macular edema that involves the center of the macula with corresponding leakage on fluorescein angiogram. Leakage will be confirmed retrospectively by the IRC. Foveal thickness of at least 250 microns (OCT center point thickness), with a standard deviation of the center point of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for the trial if any of the following criteria are present systemically, or in the study eye: Eyes with prior scatter (panretinal) photocoagulation less than 6 months prior to baseline angiography/photography or eyes in which scatter (panretinal) photocoagulation is needed now or is likely to be needed within the next 9 months (e.g. eyes with DRS high risk PDR not already adequately treated with photocoagulation). 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 for >1 disc area involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), 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 or sham treatment. Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula. Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy within 200 microns of FAZ. Any subfoveal hard exudates, or RPE atrophy (by fundus examination, fundus photograph, FA or OCT). Subjects who have received YAG laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal or grid photocoagulation, within the previous 16 weeks. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity or fundus photography. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year. Any intraocular surgery within 6 months of trial entry. Previous vitrectomy. HbA1C level >10% or recent signs of uncontrolled diabetes (3 or more episodes of severe hypoglycemia by DCCT (Diabetes Control and Complications Trial) definition [10] within 3 months of baseline, or 2 or more episodes of ketoacidosis within 1 year of baseline, or an episode of ketoacidosis within 3 months of baseline). Any of the following underlying systemic diseases including: •History or evidence of severe cardiac disease, e.g. NYHA Functional Class III or IV (Appendix 15.7), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrythmias requiring ongoing treatment. •History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation. •Clinically significant impaired renal function (serum creatinine >2.5 mg/dL or s/p renal transplant or receiving dialysis). •Clinically significant impaired hepatic function. •Stroke (within 12 months of trial entry). •Any major surgical procedure within one month of trial entry. Previous radiation to the head in the region of the study eye. Any of the following prior treatments or at anytime during the study: •Investigational agents for DME (including intravitreal, subconjunctival or subtenons corticosteroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial will be to confirm the safety and compare the efficacy of pegaptanib sodium when subjects are given intravitreous injections of 0.3 mg/eye versus sham injections in a 1:1 ratio, respectively. All subjects previously randomized to the 0.03 or 0.003 mg/eye treatment arms during the conduct of EOP1013 through EOP1013C will be given the option of either receiving injections of 0.3 mg/eye or withdrawing from the study. Injections will be given as often as every 6 weeks for 2 years, in subjects with diabetic macular edema (DME) involving the center of the macula associated with vision loss not due to ischemia. ;Secondary Objective: N/A;Primary end point(s): The primary efficacy endpoint will be the proportion of subjects who experience a >10 letter (or 2-line) improvement in vision (ETDRS) from baseline. This endpoint will be assessed at 1 year to test the significance of the comparison of the proportions of 2-line improvement in the 0.3 mg/eye dose group versus sham. The 1 year endpoint is the primary endpoint. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed