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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
  Purpose
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 Intervention Phase
Diabetic Macular Edema Drug: NOVA63035 "Corticosteroid" Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Santen SAS:

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

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT00665106     History of Changes
Other Study ID Numbers: NVG07D108
First Submitted: April 22, 2008
First Posted: April 23, 2008
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