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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen SAS

Criteria

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)