Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
Brief Summary: The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.


Options:
A: Inclusion:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age greater than 18 years
* Diagnosis of diabetes mellitus (type 1 or type 2) and serum HbA1c greater than 5.5% within 12 months of randomization
* Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea.
* Diagnosis must be confirmed by OCT images
* Foveal thickness of greater than 250, as assessed by OCT
* Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be greater than 20/800.
* In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes.
* In the opinion of the investigator, laser photocoagulation can be withheld for at least 30 days after the patient has enrolled in the study

Exclusion Criteria:

* Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
* Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
* Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
* Eyes in which the investigators do not feel appropriate to do any additional laser photocoagulation
* Proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
* Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
* Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
* Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia)
* Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
* Eyes which are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study
* Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0.
* History of vitreoretinal surgery in the study eye within 3 months of study entry
* Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medications)
* Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value greater than 12%
* Premenopausal women not using adequate contraception
* Any women who are pregnant
* International normalized ratio (INR) greater than or equal to 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
* History of gastrointestinal bleeding within 2 months of study enrollment
* History of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment
* Any patients who are on renal dialysis
B: Inclusion Criteria:

* Visual acuity impairment
* Diabetic macular edema in at least one eye
* Type 1 or type 2 diabetes mellitus
* Medication for the diabetes treatment must be stable for the last 3 months

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases
* Laser photocoagulation in the study eye for the last 3 months
* Any history of any intraocular surgery in the study eye within the past 3 months
* Blood pressure \> 160/100 mmHg

Extension Inclusion Criteria:

-Completion of the Core Study
C: Inclusion Criteria:

* Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

Exclusion Criteria:

* Monocularity,
* History of vitrectomy,
* Glaucoma or ocular hypertension,
* Significant media opacity,
* Existence of traction on the macula
D: Inclusion Criteria:

* macular edema associated with diabetes
* visual acuity between 20/50 and 20/200

Exclusion Criteria:

* recent laser therapy in the eye
* recent signs of uncontrolled diabetes
* blood pressure worse than 160/100
* severe cardiac disease

Answer: D