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Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
This study is currently recruiting participants.
Study NCT00665106   Information provided by Novagali Pharma
First Received: April 22, 2008   Last Updated: October 1, 2009   History of Changes

April 22, 2008
October 1, 2009
April 2008
October 2009   (final data collection date for primary outcome measure)
Ocular safety [ Time Frame: Over one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00665106 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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

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

 
Phase I
Interventional
Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Diabetic Macular Edema
Drug: NOVA63035 "Corticosteroid"
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
October 2010
October 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Mourad AMRANE, MD +33 (0)1 69 87 40 20 ext 22 mourad.amrane@novagali.com
United States
 
NCT00665106
Mourad AMRANE, MD, Novagali Pharma
NVG07D108
Novagali Pharma
 
 
Novagali Pharma
October 2009

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