|
| Criterion |
|
| Inclusion Criteria |
| 1) Willing, committed, and able to return for ALL clinic visits and complete all study related procedures. |
| 2) Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand and willing to sign the informed consent form. |
| 3) Signed informed consent form. |
|
| Exclusion Criteria |
| 4) Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography. |
| 5) Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety. |
| 6) History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye. |
| 7) Any ocular or periocular infection within the last 2 weeks prior to screening in either eye. |
| 8) Any history of uveitis in either eye. |
| 9) Presence or history of scleromalacia in either eye. |
| 10) Previous therapeutic radiation in the region of the study eye. |
| 11) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications. |
| 12) Participation as a patient in any clinical study within the 12 weeks prior to day 1. |
| 13) Any systemic or ocular treatment with an investigational agent in the past 12 weeks prior to day 1. |
| 14) The use of long acting steroids, either systemically or intraocularly, in the 6 months prior to day 1. |
| 15) Any history of allergy to povidone iodine. |
| 16) Presence of any contraindications indicated in the FDA approved label for ranibizumab (Lucentis®; Genentech Inc., South San Francisco, CA). |
| 17) Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening); IUD; Depo-Provera® (Pfizer, Inc. New York); Norplant® System (Pfizer, Inc. New York) implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly. |
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