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

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

October 1, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular safety [ Time Frame: Over one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00665106 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Drug: NOVA63035 "Corticosteroid"

Study Arms / Comparison Groups

Experimental: 5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
Experimental: 5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
Experimental: 5 up to 6 patients per arm. Oily solution at 3.4% of drug product.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mourad AMRANE, MD

+33 (0)1 69 87 40 20 ext 22

mourad.amrane@novagali.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00665106

Responsible Party

Mourad AMRANE, MD, Novagali Pharma

Study ID Numbers ^ICMJE

NVG07D108

Study Sponsor ^ICMJE

Novagali Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Novagali Pharma

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP