Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Phase 1
Completed
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: NOVA63035 "Corticosteroid"
- Registration Number
- NCT00665106
- Lead Sponsor
- Santen SAS
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cohort 3 NOVA63035 "Corticosteroid" 5 up to 6 patients per arm. Emulsion at 3.2% of drug product. cohort 2 NOVA63035 "Corticosteroid" 5 up to 6 patients per arm. Emulsion at 0.8% of drug product. cohort 4 NOVA63035 "Corticosteroid" 5 up to 6 patients per arm. Oily solution at 3.4% of drug product. cohort 1 NOVA63035 "Corticosteroid" 5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
- Primary Outcome Measures
Name Time Method Ocular safety Over one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States