Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema

NCT ID: NCT00886808

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-06-30

Brief Summary

The goal of the study is to evaluate the safety and tolerability of 4 different doses of iCo-007 Intravitreal Injection in patients with diffuse diabetic macular edema.

Conditions

Diffuse Diabetic Macular Edema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

110 microgram dose of iCo-007 Intravitreal Injection

Group Type: EXPERIMENTAL

iCo-007 Intravitreal Injection

Intervention Type: DRUG

single dose iCo-007 Intravitreal Injection

2

350microgram dose of iCo-007 Intravitreal Injection

Group Type: EXPERIMENTAL

iCo-007 Intravitreal Injection

Intervention Type: DRUG

single dose iCo-007 Intravitreal Injection

3

700microgram dose of iCo-007 Intravitreal Injection

Group Type: EXPERIMENTAL

iCo-007 Intravitreal Injection

Intervention Type: DRUG

single dose iCo-007 Intravitreal Injection

4

1,000microgram dose of iCo-007 Intravitreal Injection

Group Type: EXPERIMENTAL

iCo-007 Intravitreal Injection

Intervention Type: DRUG

single dose iCo-007 Intravitreal Injection

Interventions

iCo-007 Intravitreal Injection

single dose iCo-007 Intravitreal Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women 18 years of age or older

2. Confirmed diagnosis of diabetes mellitus type I or II (both, insulin or non-insulin dependent)

3. Subjects who have moderate to severe non-proliferative diabetic retinopathy (NPDR), as defined by ETDRS criteria, and diffuse DME within 300 microns from the center of the macula in the study eye (with or without cystoid changes) confirmed by FA.

4. Retinal thickness must be at least 250 microns in the central subfield, as shown by OCT

5. Best-corrected visual acuity between 60 and 15 letters measured with ETDRS charts (approximately 20/63 to 20/500 with Snellen charts)

6. Woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening (serum). Both men and women are required to practice an adequate method of birth control

7. Able and willing to sign an approved informed consent form and return for all scheduled study visits

Exclusion Criteria

1. Subjects with macular or perimacular edema secondary to an etiology other than diabetes mellitus

2. Subjects with concurrent retinal diseases or conditions in the study eye (including conditions requiring urgent PRP), glaucoma (or ocular hypertension), retinal vascular occlusion, exudative age-related macular degeneration (drusen permitted), tear (rip) of the retinal pigment epithelium, a vitelliform-like lesion of the outer retina (e.g. pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis or retinal-lesion anastomosis

3. Subjects who have any additional ocular disease or condition which could compromise treatment safety, visual acuity or interfere with assessment of the macular edema, such as ocular inflammation, amblyopia, anterior ischemic optic neuropathy, media opacity, cataract

4. Subjects who have diffuse DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)

5. Allergy to fluorescein dye

6. Subjects who had intraocular surgery, photocoagulation, intravitreal or subfoveal injection, topical or systemic steroids or who received any experimental treatment as part of another clinical trial within the last 3 months of the study start (in case of Anecortave within the last 6 months, any panretinal photocoagulation prior to study start)

7. Subjects with uncontrolled diabetes (glycosylated hemoglobin Hb A1c >12%)

8. Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment

9. Subjects with congestive heart disease or any unstable cardiac condition

10. Subjects with clinically significantly impaired renal function (serum creatinine >2.0 mg/dL) and/or moderate to severe hepatic impairment (subjects with >2.5 times the upper limit of the normal range for aspartate transaminase [AST], alanine transaminase [ALT], or total bilirubin)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iCo Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Retina-Vitreous Associates Medical Group

Los Angeles, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Duke Eye Center

Durham, North Carolina, United States

Valley Retina Institute

McAllen, Texas, United States

Countries

United States

Other Identifiers

2006-007-01-DME

Identifier Type: -

Identifier Source: org_study_id