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

Diffuse Diabetic Macular Edema Clinical Trial

Official title:

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of iCo-007 Intravitreal Injection in Subjects With Diffuse Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886808
• Other study ID #: 2006-007-01-DME
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2009
• Last updated: March 21, 2012
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2012
• Source: iCo Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Diffuse Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• iCo-007 Intravitreal Injection
single dose iCo-007 Intravitreal Injection

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina
United States	Retina-Vitreous Associates Medical Group	Los Angeles	California
United States	Valley Retina Institute	McAllen	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
iCo Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.		At multiple points after injection up to and including 6 months	Yes
Secondary	To assess the systemic pharmacokinetics of iCo-007 after intravitreal administration. To assess change in retinal thickness relative to baseline as determined by OCT. To assess change in best corrected visual acuity relative to baseline.		At multiple points after injection up to and including 6 months	Yes