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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665106
First Posted: April 23, 2008
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santen SAS
April 22, 2008
April 23, 2008
May 27, 2015
April 2008
September 2011   (Final data collection date for primary outcome measure)
Ocular safety [ Time Frame: Over one year ]
Same as current
Complete list of historical versions of study NCT00665106 on ClinicalTrials.gov Archive Site
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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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Diabetic Macular Edema
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
  • Experimental: cohort 1
    5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
    Intervention: Drug: NOVA63035 "Corticosteroid"
  • Experimental: cohort 2
    5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
    Intervention: Drug: NOVA63035 "Corticosteroid"
  • Experimental: cohort 3
    5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
    Intervention: Drug: NOVA63035 "Corticosteroid"
  • Experimental: cohort 4
    5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
    Intervention: Drug: NOVA63035 "Corticosteroid"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2011
September 2011   (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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00665106
NVG07D108
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Santen SAS
Santen SAS
Not Provided
Not Provided
Santen SAS
May 2015

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