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

This study is currently recruiting participants.

Verified by Novagali Pharma, October 2009

First Received: April 22, 2008 Last Updated: October 1, 2009 History of Changes

Sponsor:	Novagali Pharma
Information provided by:	Novagali Pharma
ClinicalTrials.gov Identifier:	NCT00665106

Purpose

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

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: NOVA63035 "Corticosteroid"	Phase I

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Corticosteroids

U.S. FDA Resources

Further study details as provided by Novagali Pharma:

Primary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
cohort 1: Experimental 5 up to 6 patients per arm. Emulsion at 0.8% of drug product.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye
cohort 2: Experimental 5 up to 6 patients per arm. Emulsion at 0.8% of drug product.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye
cohort 3: Experimental 5 up to 6 patients per arm. Emulsion at 3.2% of drug product.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye
cohort 4: Experimental 5 up to 6 patients per arm. Oily solution at 3.4% of drug product.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665106

Contacts

Contact: Mourad AMRANE, MD

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

mourad.amrane@novagali.com

Locations

United States, Indiana
Midwest Eye Institute	Recruiting
Indianapolis, Indiana, United States, 46280
Contact 317-817-1414
Principal Investigator: Raj MATURI, MD

Sponsors and Collaborators

Novagali Pharma

More Information

No publications provided

Responsible Party:	Novagali Pharma ( Mourad AMRANE, MD )
Study ID Numbers:	NVG07D108
Study First Received:	April 22, 2008
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00665106 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novagali Pharma:

Diabetic macular edema
Diabetes
Diabetic retinopathy

Additional relevant MeSH terms:

Eye Diseases
Vascular Diseases
Diabetes Mellitus
Retinal Degeneration
Edema
Endocrine System Diseases
Macular Degeneration

Diabetic Angiopathies
Macular Edema
Signs and Symptoms
Diabetic Retinopathy
Cardiovascular Diseases
Retinal Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009