Safety and Tolerability of NOVA63035 "Corticosteroid" 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

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NOVA63035 "Corticosteroid"

Drug

Single injection in the study eye

Primary outcomes

Ocular safety

Time frame: Over one year

Sponsors and collaborators

Lead sponsor

Santen SAS

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Apr 23, 2008
Registry last updated: May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed