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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT00665106
First received: April 22, 2008
Last updated: May 26, 2015
Last verified: May 2015

April 22, 2008
May 26, 2015
April 2008
September 2011   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00665106
NVG07D108
Not Provided
Novagali Pharma
Novagali Pharma
Not Provided
Not Provided
Novagali Pharma
May 2015

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