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Sponsored by: |
Novagali Pharma |
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Information provided by: | Novagali Pharma |
ClinicalTrials.gov Identifier: | NCT00665106 |
Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of three doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Drug: NOVA63035 "Corticosteroid" |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
5 up to 6 patients per arm. 3 arms with 3 different doses.
|
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
|
2: Experimental
5 up to 6 patients per arm. 3 arms with 3 different doses.
|
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
|
3: Experimental
5 up to 6 patients per arm. 3 arms with 3 different doses.
|
Drug: NOVA63035 "Corticosteroid"
Single injection in the study eye
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mourad AMRANE, MD | +33 (0)1 69 87 40 20 ext 22 | mourad.amrane@novagali.com |
United States, Indiana | |
Midwest Eye Institute | Recruiting |
Indianapolis, Indiana, United States, 46280 | |
Contact 317-817-1414 | |
Principal Investigator: Raj MATURI, MD |
Responsible Party: | Novagali Pharma ( Mourad AMRANE, MD ) |
Study ID Numbers: | NVG07D108 |
Study First Received: | April 22, 2008 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00665106 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetic macular edema Diabetes Diabetic retinopathy |
Eye Diseases Diabetes Mellitus Vascular Diseases Retinal Degeneration Edema Endocrine System Diseases Macular Degeneration Diabetic Angiopathies |
Macular Edema Signs and Symptoms Diabetic Retinopathy Neoplasm Metastasis Endocrinopathy Retinal Diseases Diabetes Complications |
Eye Diseases Vascular Diseases Diabetes Mellitus Retinal Degeneration Edema Endocrine System Diseases Macular Degeneration |
Diabetic Angiopathies Macular Edema Signs and Symptoms Diabetic Retinopathy Cardiovascular Diseases Retinal Diseases Diabetes Complications |