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

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ClinicalTrials.gov Identifier: NCT00665106
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Santen SAS

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: NOVA63035 "Corticosteroid" Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: cohort 1
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
Experimental: cohort 2
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
Experimental: cohort 3
5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
Experimental: cohort 4
5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye



Primary Outcome Measures :
  1. Ocular safety [ Time Frame: Over one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665106


Locations
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
Sponsors and Collaborators
Santen SAS

Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT00665106     History of Changes
Other Study ID Numbers: NVG07D108
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Santen SAS:
Diabetic macular edema
Diabetes
Diabetic retinopathy

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases