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

Purpose

Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of three doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy

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

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Diabetic Eye Problems Edema Retinal Disorders

ChemIDplus related topics:

Corticosteroids

U.S. FDA Resources

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

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:	18
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 5 up to 6 patients per arm. 3 arms with 3 different doses.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye
2: Experimental 5 up to 6 patients per arm. 3 arms with 3 different doses.	Drug: NOVA63035 "Corticosteroid" Single injection in the study eye
3: Experimental 5 up to 6 patients per arm. 3 arms with 3 different doses.	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

Responsible Party:	Novagali Pharma ( Mourad AMRANE, MD )
Study ID Numbers:	NVG07D108, Retiject(r)
First Received:	April 22, 2008
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00665106
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novagali Pharma:

Diabetic macular edema

Diabetes

Diabetic retinopathy

Study placed in the following topic categories:

Eye Diseases

Diabetes Mellitus

Vascular Diseases

Retinal Degeneration

Edema

Endocrine System Diseases

Macular Degeneration

Diabetic Angiopathies

Macular Edema

Signs and Symptoms

Diabetic Retinopathy

Neoplasm Metastasis

Endocrinopathy

Retinal Diseases

Diabetes Complications

Retinal degeneration

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2008

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