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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.   Last updated on April 24, 2008.   Information provided by Novagali Pharma

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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
Brief Summary

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
Detailed Description
Study Phase Phase I
Study Type † Interventional
Study Design † Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Ocular safety [ Time Frame: Over one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure †
Condition † Diabetic Macular Edema
Intervention † Drug: NOVA63035 "Corticosteroid"
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 18
Start Date † April 2008
Completion Date February 2010
Eligibility 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)
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Mourad AMRANE, MD     +33 (0)1 69 87 40 20 ext 22     mourad.amrane@novagali.com    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00665106
Organization ID NVG07D108
Secondary IDs †† Retiject(r)
Study Sponsor † Novagali Pharma
Collaborators ††
Investigators †
Information Provided By Novagali Pharma
Verification Date April 2008
First Received Date † April 22, 2008
Last Updated Date April 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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