CompletedPhase 1

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

United States15 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men or women 18 years of age or older
. Confirmed diagnosis of diabetes mellitus type I or II (both, insulin or non-insulin dependent)
. 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.
. Retinal thickness must be at least 250 microns in the central subfield, as shown by OCT
. Best-corrected visual acuity between 60 and 15 letters measured with ETDRS charts (approximately 20/63 to 20/500 with Snellen charts)
. 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
. Able and willing to sign an approved informed consent form and return for all scheduled study visits

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.

Timeframe: At multiple points after injection up to and including 6 months

Trial details

NCT IDNCT00886808

SponsoriCo Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Diffuse Diabetic Macular Edema trials