Trials Sponsors Conditions Drugs Pricing

Conditions

Diffuse Diabetic Macular Edema

Keywords

DME, Diabetic Retinopathy, Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

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 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.
At multiple points after injection up to and including 6 months

Study Arms (4)

1

EXPERIMENTAL

110 microgram dose of iCo-007 Intravitreal Injection

Drug: iCo-007 Intravitreal Injection

2

EXPERIMENTAL

350microgram dose of iCo-007 Intravitreal Injection

Drug: iCo-007 Intravitreal Injection

3

EXPERIMENTAL

700microgram dose of iCo-007 Intravitreal Injection

Drug: iCo-007 Intravitreal Injection

Interventions

iCo-007 Intravitreal InjectionDrug

single dose iCo-007 Intravitreal Injection

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men or women 18 years of age or older
Confirmed diagnosis of diabetes mellitus type I or II (both, insulin or non-insulin dependent)

Sponsors & Collaborators

iCo Therapeutics Inc.
Industrylead

Study Sites (4)

Retina-Vitreous Associates Medical Group

Los Angeles, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Duke Eye Center

Durham, North Carolina, United States

Valley Retina Institute

McAllen, Texas, United States

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations