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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iCo Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00886808
First received: April 22, 2009
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diffuse Diabetic Macular Edema
Drug: iCo-007 Intravitreal Injection
Phase 1

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

Resource links provided by NLM:


Further study details as provided by iCo Therapeutics Inc.:

Primary Outcome Measures:
  • Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007. [ Time Frame: At multiple points after injection up to and including 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At multiple points after injection up to and including 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00886808

Locations
United States, California
Retina-Vitreous Associates Medical Group
Los Angeles, California, United States
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States
United States, Texas
Valley Retina Institute
McAllen, Texas, United States
Sponsors and Collaborators
iCo Therapeutics Inc.
  More Information

No publications provided

Responsible Party: iCo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00886808     History of Changes
Other Study ID Numbers: 2006-007-01-DME
Study First Received: April 22, 2009
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by iCo Therapeutics Inc.:
DME, Diabetic Retinopathy, Diabetic Macular Edema

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014