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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:
Information provided by (Responsible Party):
Santen SAS
ClinicalTrials.gov Identifier:
NCT00665106
First received: April 22, 2008
Last updated: May 26, 2015
Last verified: May 2015
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 22, 2008
Last Updated: May 26, 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

ClinicalTrials.gov processed this record on August 21, 2017