Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
NCT ID: NCT00665106
Last Updated: 2015-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2008-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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cohort 1
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
NOVA63035 "Corticosteroid"
Single injection in the study eye
cohort 2
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
NOVA63035 "Corticosteroid"
Single injection in the study eye
cohort 3
5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
NOVA63035 "Corticosteroid"
Single injection in the study eye
cohort 4
5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
NOVA63035 "Corticosteroid"
Single injection in the study eye
Interventions
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NOVA63035 "Corticosteroid"
Single injection in the study eye
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with diabetes mellitus and presenting diabetic retinopathy
Exclusion Criteria
* History of current ocular hypertension or glaucoma in either eye defined
* Any significant ocular disease (other than diabetic retinopathy)
18 Years
ALL
No
Sponsors
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Santen SAS
INDUSTRY
Responsible Party
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Locations
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Midwest Eye Institute
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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NVG07D108
Identifier Type: -
Identifier Source: org_study_id
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