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

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

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.

Study Overview

• Status: Completed
• Conditions: Diffuse Diabetic Macular Edema
• Intervention / Treatment: Drug: iCo-007 Intravitreal Injection

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 110 microgram dose of iCo-007 Intravitreal Injection	Drug: iCo-007 Intravitreal Injection; single dose iCo-007 Intravitreal Injection
Experimental: 2; 350microgram dose of iCo-007 Intravitreal Injection	Drug: iCo-007 Intravitreal Injection; single dose iCo-007 Intravitreal Injection
Experimental: 3; 700microgram dose of iCo-007 Intravitreal Injection	Drug: iCo-007 Intravitreal Injection; single dose iCo-007 Intravitreal Injection
Experimental: 4; 1,000microgram dose of iCo-007 Intravitreal Injection	Drug: iCo-007 Intravitreal Injection; single dose iCo-007 Intravitreal Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.	At multiple points after injection up to and including 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: iCo Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: DME, Diabetic Retinopathy, Diabetic Macular Edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: 2006-007-01-DME