Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy

Inclusion Criteria:

• M & F 18 years and older
• Diagnosed with diabetes mellitus and presenting diabetic retinopathy

Exclusion Criteria:

• Monocular
• History of current ocular hypertension or glaucoma in either eye defined
• Any significant ocular disease (other than diabetic retinopathy)