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| Sponsored by: |
Novagali Pharma |
| Information provided by: | Novagali Pharma |
| ClinicalTrials.gov Identifier: | NCT00665106 |
Purpose
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 |
| Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
| MedlinePlus related topics: | Diabetic Eye Problems Edema Retinal Disorders |
| ChemIDplus related topics: | Corticosteroids |
| 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
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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
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Novagali Pharma |
More Information
| Responsible Party: | Novagali Pharma ( Mourad AMRANE, MD ) |
| Study ID Numbers: | NVG07D108, Retiject(r) |
| First Received: | April 22, 2008 |
| Last Updated: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00665106 |
| Health Authority: | United States: Food and Drug Administration |
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