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

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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
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: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration 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:	June 2011
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

Locations

United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280

Sponsors and Collaborators

Novagali Pharma

More Information

No publications provided

Responsible Party:	Mourad AMRANE, MD, Novagali Pharma
ClinicalTrials.gov Identifier:	NCT00665106 History of Changes
Other Study ID Numbers:	NVG07D108
Study First Received:	April 22, 2008
Last Updated:	July 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novagali Pharma:

Diabetic macular edema
Diabetes
Diabetic retinopathy

Additional relevant MeSH terms:

Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on February 12, 2012