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

• Sponsor: Santen SAS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00665106
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4
• Duration (Months): 41
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: NOVA63035 "Corticosteroid"	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Ocular safety [Over one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Midwest Eye Institute	Indianapolis	Indiana	United States	46280

Sponsors and Collaborators

• Santen SAS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen SAS
• ClinicalTrials.gov Identifier: NCT00665106
• Other Study ID Numbers: NVG07D108
• First Posted: Apr 23, 2008
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Keywords provided by Santen SAS: Diabetic macular edema; Diabetes; Diabetic retinopathy
• Additional relevant MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema

Study Results

No Results Posted as of May 27, 2015