Diffuse Diabetic Macular EdemaPhase 1NCT00886808
Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema
A Phase 1 study testing iCo-007 Intravitreal Injection in people with Diffuse Diabetic Macular Edema, run by iCo Therapeutics Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Diabetic Macular Edema
- What is being tested?
- iCo-007 Intravitreal Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
- Subjects who have diffuse DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
- Allergy to fluorescein dye
- 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)
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- Subjects with uncontrolled diabetes (glycosylated hemoglobin Hb A1c >12%)
- Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
- Subjects with congestive heart disease or any unstable cardiac condition
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke Eye Center
Durham, North Carolina
Retina-Vitreous Associates Medical Group
Los Angeles, California
Valley Retina Institute
McAllen, Texas
Bascom Palmer Eye Institute
Miami, Florida
About this study
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
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
- Being tested
- iCo-007 Intravitreal Injection
- Keywords
- DME, Diabetic Retinopathy, Diabetic Macular Edema
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCo-007 Intravitreal InjectionDrug
single dose iCo-007 Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 110 microgram dose of iCo-007 Intravitreal Injection Receives: Drug: iCo-007 Intravitreal Injection |
| 2 | Experimental | 350microgram dose of iCo-007 Intravitreal Injection Receives: Drug: iCo-007 Intravitreal Injection |
| 3 | Experimental | 700microgram dose of iCo-007 Intravitreal Injection Receives: Drug: iCo-007 Intravitreal Injection |
| 4 | Experimental | 1,000microgram dose of iCo-007 Intravitreal Injection Receives: Drug: iCo-007 Intravitreal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007.
Measured: At multiple points after injection up to and including 6 months
Secondary outcomes (1)
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.
Measured: At multiple points after injection up to and including 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- iCo Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886808
- Sponsor's protocol ID
- 2006-007-01-DME
- Status last verified
- Mar 2012
- First submitted
- 22 Apr 2009
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00886808
- Acronym / sponsor ID
- 2006-007-01-DME
- Conditions
- Diffuse Diabetic Macular Edema
- Keywords
- DME, Diabetic Retinopathy, Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- iCo Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: iCo-007 Intravitreal Injection110 microgram dose of iCo-007 Intravitreal Injection |
| 2 | Experimental | Drug: iCo-007 Intravitreal Injection350microgram dose of iCo-007 Intravitreal Injection |
| 3 | Experimental | Drug: iCo-007 Intravitreal Injection700microgram dose of iCo-007 Intravitreal Injection |
| 4 | Experimental | Drug: iCo-007 Intravitreal Injection1,000microgram dose of iCo-007 Intravitreal Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
- 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
- Subjects who have diffuse DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
- Allergy to fluorescein dye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCo-007 Intravitreal Injectionsingle dose iCo-007 Intravitreal Injection | Drug | 1, 2, 3, 4 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iCo-007 Intravitreal Injection in people with Diffuse Diabetic Macular Edema, run by iCo Therapeutics Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.