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Table 2 Exclusion criteria

From: Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)

Women of child-bearing potential, unless they are using two birth control methods.

Pregnant or nursing (lactating) women.

Inability to comply with study procedures.

Active intraocular inflammation (grade + or above) in either eye at enrolment.

Any active infection in either eye at the time of enrolment.

History of uveitis in either eye at any time.

Structural damage within 600 μm of the centre of the macula in the study eye likely to preclude improvement in visual acuity following in the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.

Uncontrolled glaucoma in the study eye at screening (IOP > 24 mmHg on medication or according to investigator’s judgment).

Neovascularization of the iris in the study eye.

Evidence of vitreomacular traction in the study eye.

Active untreated proliferative diabetic retinopathy in the study eye.

Any intraocular surgery in the study eye within 3 months prior to randomization.

History of vitrectomy in study eye regardless of time prior to randomization.

Planned medical or surgical intervention during the 6 months study period.

Panretinal laser photocoagulation in the study eye within 3 months prior to or during the study.

Focal/grid laser photocoagulation in the study eye 3 months prior to study entry.

Treatment with anti-angiogenic drugs in the study eye within 3 months prior to randomization.

Use of other investigational drugs at the time of enrolment, or within 3 month or 5 half-lives from enrolment, whichever is longer.

History of intravitreal corticosteroids in phakic eye within 18 months prior to randomization or in post-cataract surgery study eye within 4 months prior to randomization.

Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids.

History of stroke or transient ischemic attack (TIA) within 6 months prior to enrolment.

Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening.

Blood pressure systolic > 165 mm Hg or diastolic > 105 mmHg at screening and randomization.

Hypertension or change in antihypertensive treatment within 1 month preceding randomization.

Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol.

Known hypersensitivity to fluorescein, ranibizumab or bevacizumab or any component thereof or drugs of similar chemical classes.

Any type of advanced, severe or unstable disease or its treatment, that may interfere with primary and/or secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.

Concomitant conditions in the study eye which would, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.

Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 6-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)