Back to resultsSafety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NOVA63035 "Corticosteroid"
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Diabetes, Diabetic retinopathy
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)
Sites / Locations
- Midwest Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
cohort 1
cohort 2
cohort 3
cohort 4
Arm Description
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
Outcomes
Primary Outcome Measures
Ocular safety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00665106
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen SAS
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic macular edema, Diabetes, Diabetic retinopathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cohort 1
Arm Type
Experimental
Arm Description
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
Arm Title
cohort 2
Arm Type
Experimental
Arm Description
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
Arm Title
cohort 3
Arm Type
Experimental
Arm Description
5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
Arm Title
cohort 4
Arm Type
Experimental
Arm Description
5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
Intervention Type
Drug
Intervention Name(s)
NOVA63035 "Corticosteroid"
Intervention Description
Single injection in the study eye
Primary Outcome Measure Information:
Title
Ocular safety
Time Frame
Over one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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