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NCT00665106 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00665106
Other study ID # NVG07D108
Secondary ID
Status Completed
Phase Phase 1
First received April 22, 2008
Last updated May 26, 2015
Start date April 2008
Est. completion date September 2011

Study information
Verified date May 2015
Source Novagali Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• NOVA63035 "Corticosteroid"
Single injection in the study eye

Locations
Country Name City State
United States Midwest Eye Institute Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Novagali Pharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular safety Over one year Yes
See also
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