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

Santen

Status and phase: Completed; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Drug: NOVA63035 "Corticosteroid"

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665106

NVG07D108

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

cohort 1

Experimental group

Description:

5 up to 6 patients per arm. Emulsion at 0.8% of drug product.

Treatment:

Drug: NOVA63035 "Corticosteroid"

cohort 2

Experimental group

Description:

5 up to 6 patients per arm. Emulsion at 0.8% of drug product.

Treatment:

Drug: NOVA63035 "Corticosteroid"

cohort 3

Experimental group

Description:

5 up to 6 patients per arm. Emulsion at 3.2% of drug product.

Treatment:

Drug: NOVA63035 "Corticosteroid"

cohort 4

Experimental group

Description:

5 up to 6 patients per arm. Oily solution at 3.4% of drug product.

Treatment:

Drug: NOVA63035 "Corticosteroid"