PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

Exclusion Criteria

• •1. History of vitrectomy.
• •2. History of IVT injection in study eye within last 6 months.
• •3. History of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
• •4. History of uveitis or endophthalmitis in either eye.
• •5. Any active inflammatory condition in study eye.
• •6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
• •7. Any medical condition, concomitant therapy or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye.
• •8. Intraocular pressure in either eye ≥25 mmHg on maximal medication.
• •9. Cataract surgery and laser corneal surgery within 3 months prior to dosing in the study eye and all other intraocular surgeries at any time.
• •10. Participation in a concurrent interventional study within 30 days prior to dosing.
• •1. History of panretinal photocoagulation within 6 months or macular laser photocoagulation within 3 months of prior to dosing in the study eye.
• •2. Any IVT injection therapy performed in the study eye within 3 months prior to dosing.
• •3. Iris neovascularization, vitreous hemorrhage, tractional retinal detachment, vitreomacular traction, clinically significant epiretinal membrane or clinically significant preretinal fibrosis involving the macula in the study eye.
• •4. History of vitreoretinal surgery or incisional glaucoma surgery in the study eye.
• •5. Prior intraocular surgery or corneal laser surgery, performed within 3 months prior to dosing in the study eye.
• •6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
• •7. High risk (in the opinion of the Investigator) proliferative diabetic retinopathy (PDR) in the study eye.
• •8. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
• •9. Monocular subjects.
• •10. History of idiopathic or autoimmune uveitis in either eye.
• •11. Aphakia or absence of the posterior capsule in the study eye.
• •12. 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.
• •13. Uncontrolled glaucoma in either eye.
• •14. Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
• •15. Use of corticosteroids that, in the Investigator's opinion, may change the status of the subject's diabetic retinopathy in the study eye.