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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Novagali Pharma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT00665106
First received: April 22, 2008
Last updated: July 15, 2010
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Novagali Pharma:

Primary Outcome Measures:
  • Ocular safety [ Time Frame: Over one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: April 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: October 2009 (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
Genders Eligible for Study:   Both
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
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
Novagali Pharma
  More Information

No publications provided

Responsible Party: Mourad AMRANE, MD, Novagali Pharma
ClinicalTrials.gov Identifier: NCT00665106     History of Changes
Other Study ID Numbers: NVG07D108
Study First Received: April 22, 2008
Last Updated: July 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novagali Pharma:
Diabetic macular edema
Diabetes
Diabetic retinopathy

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

ClinicalTrials.gov processed this record on April 23, 2014