|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy | ||||
| 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 | ||||
| Brief Summary | 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 |
||||
| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Ocular safety [ Time Frame: Over one year ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Diabetic Macular Edema | ||||
| Intervention † | Drug: NOVA63035 "Corticosteroid" | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 18 | ||||
| Start Date † | April 2008 | ||||
| Completion Date | February 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00665106 | ||||
| Organization ID | NVG07D108 | ||||
| Secondary IDs †† | Retiject(r) | ||||
| Study Sponsor † | Novagali Pharma | ||||
| Collaborators †† | |||||
| Investigators † | |||||
| Information Provided By | Novagali Pharma | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 22, 2008 | ||||
| Last Updated Date | April 24, 2008 | ||||