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

Santen SAS20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

NOVA63035 "Corticosteroid"DRUG

Single injection in the study eye

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Midwest Eye Institute

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Ocular safety

Time frame: Over one year

Data from ClinicalTrials.gov

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