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A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study) (iDEAL)

Primary Purpose

Diabetic Macular Edema

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
iCo-007 350 mcg
iCo-007 700 mcg
iCo-007 350 mcg and Laser
Ranibizumab and iCo-007 350 mcg
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema (DME)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥5.5% and HbA1c ≤13%; have non-proliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period
  • Have diabetic macular edema with central subfield thickness of ≥250 microns (confirmed by Stratus Time-Domain(TD) OCT

  • Have best corrected visual acuity (ETDRS) that is Snellen equivalent of

    • 20/32 and ≥20/320, inclusive
  • Be willing and able to sign an approved written informed consent. If a patient has a central nervous system disorder (i.e. dementia) that will not allow him/her to understand the consent independently, the patient will not be allowed to join the study
  • Be able to attend all scheduled study visits
  • Women who are not lactating or pregnant and are willing to use adequate contraception during the study period, if appropriate

Exclusion Criteria:

  • Have macular or perimacular edema secondary to an etiology other than diabetes
  • Have concurrent retinal diseases other than diabetic retinopathy
  • Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
  • Participant has a history of prior pars plana vitrectomy
  • Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year
  • Subjects who have DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
  • Have an allergy to fluorescein dye
  • Have terminal renal disease (on active kidney dialysis), cerebral vascular accident(including TIA), myocardial infarction or congestive heart disease within 6 months of study enrollment, liver damage (2x upper limit of normal range for aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or total bilirubin). Patients who may have received renal transplant in the past and now have stable renal function, may participate in the study
  • Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
  • Have a history of panretinal photocoagulation (PRP) in the study eye within 3 months of study entry or are likely to have PRP in the study eye during study participation
  • Had macular photocoagulation or ocular surgery within 3 months of study entry in the study eye
  • Received intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry or anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, VEGF-TRAP, protein kinase C inhibitor, etc.) within 2 months of study entry; history of usage of topical or systemic steroids within 3 months of study entry is not an exclusion

Sites / Locations

  • Stanley M Truhlsen Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Drug: iCo-007 350 mcg iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4

Drug: iCo-007 700 mcg iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4

Drug: iCo-007 350 mcg and Laser iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation

Drug: Ranibizumab and iCo-007 350 mcg Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later

Outcomes

Primary Outcome Measures

Change in VA From Baseline to Month 8
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8

Secondary Outcome Measures

Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;
Change in VA From Baseline to Month 12
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Group 1
Change in Retinal Thickness Measured
measured by OCT
Duration of iCo-007 Treatment Effect
treatment effect as measured by VA and OCY thickness
Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
cmax

Full Information

First Posted
March 15, 2012
Last Updated
July 28, 2017
Sponsor
Johns Hopkins University
Collaborators
Juvenile Diabetes Research Foundation, iCo Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01565148
Brief Title
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
Acronym
iDEAL
Official Title
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema With Involvement of the FoveAL Center (the iDEAL Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Patient's disease progressed and Vision Dropped which led to exit from the study
Study Start Date
February 2012 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Juvenile Diabetes Research Foundation, iCo Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema (DME)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Drug: iCo-007 350 mcg iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Drug: iCo-007 700 mcg iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Drug: iCo-007 350 mcg and Laser iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Drug: Ranibizumab and iCo-007 350 mcg Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
Intervention Type
Drug
Intervention Name(s)
iCo-007 350 mcg
Other Intervention Name(s)
Group 1
Intervention Description
iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
Intervention Type
Drug
Intervention Name(s)
iCo-007 700 mcg
Other Intervention Name(s)
Group 2
Intervention Description
iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
Intervention Type
Drug
Intervention Name(s)
iCo-007 350 mcg and Laser
Other Intervention Name(s)
Group 3
Intervention Description
iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
Intervention Type
Drug
Intervention Name(s)
Ranibizumab and iCo-007 350 mcg
Other Intervention Name(s)
Group 4
Intervention Description
Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
Primary Outcome Measure Information:
Title
Change in VA From Baseline to Month 8
Description
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
Time Frame
Baseline to month 8
Secondary Outcome Measure Information:
Title
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Description
Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;
Time Frame
Baseline to month 8
Title
Change in VA From Baseline to Month 12
Description
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
Time Frame
Baseline to month 12
Title
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Description
Group 1
Time Frame
Baseline to month 8
Title
Change in Retinal Thickness Measured
Description
measured by OCT
Time Frame
Baseline to month 12
Title
Duration of iCo-007 Treatment Effect
Description
treatment effect as measured by VA and OCY thickness
Time Frame
Baseline to month 12
Title
Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
Description
cmax
Time Frame
Baseline to month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥5.5% and HbA1c ≤13%; have non-proliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period Have diabetic macular edema with central subfield thickness of ≥250 microns (confirmed by Stratus Time-Domain(TD) OCT Have best corrected visual acuity (ETDRS) that is Snellen equivalent of 20/32 and ≥20/320, inclusive Be willing and able to sign an approved written informed consent. If a patient has a central nervous system disorder (i.e. dementia) that will not allow him/her to understand the consent independently, the patient will not be allowed to join the study Be able to attend all scheduled study visits Women who are not lactating or pregnant and are willing to use adequate contraception during the study period, if appropriate Exclusion Criteria: Have macular or perimacular edema secondary to an etiology other than diabetes Have concurrent retinal diseases other than diabetic retinopathy Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study Participant has a history of prior pars plana vitrectomy Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year Subjects who have DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns) Have an allergy to fluorescein dye Have terminal renal disease (on active kidney dialysis), cerebral vascular accident(including TIA), myocardial infarction or congestive heart disease within 6 months of study enrollment, liver damage (2x upper limit of normal range for aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or total bilirubin). Patients who may have received renal transplant in the past and now have stable renal function, may participate in the study Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment Have a history of panretinal photocoagulation (PRP) in the study eye within 3 months of study entry or are likely to have PRP in the study eye during study participation Had macular photocoagulation or ocular surgery within 3 months of study entry in the study eye Received intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry or anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, VEGF-TRAP, protein kinase C inhibitor, etc.) within 2 months of study entry; history of usage of topical or systemic steroids within 3 months of study entry is not an exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana V. Do, MD
Organizational Affiliation
Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Wong, MD
Organizational Affiliation
Austin Retina Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Tolentino, MD
Organizational Affiliation
Center for Retina Macula Disease
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prema Abraham, MD
Organizational Affiliation
Black Hills Regional Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene Lit, MD
Organizational Affiliation
East Bay Retina Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Elman, MD
Organizational Affiliation
Elman Retina Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas A. Barnard, MD
Organizational Affiliation
Florida Retina Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas A. Ciulla, MD
Organizational Affiliation
Midwest Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard B. Rosen, MD
Organizational Affiliation
New York Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry L. Hudson, MD
Organizational Affiliation
Retina Centers, P.C.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pravin Dugel, MD
Organizational Affiliation
Retina Consultants of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregg T. Kokame, MD
Organizational Affiliation
Retina Consultants of Hawaii, Pali Momi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M. Brown, MD
Organizational Affiliation
Retina Consultants Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry S. Halperin, MD
Organizational Affiliation
Retina Group of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goergios Papastergio, MD
Organizational Affiliation
Retina Institute of Hawaii
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron P. Gallemore, MD. PhD
Organizational Affiliation
Retina Macula Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian B. Berger, MD
Organizational Affiliation
Retina Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Homayoun Tabandeh, MD
Organizational Affiliation
Retina Vitreous Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis M. Marcus, MD
Organizational Affiliation
Southeast Retina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert S. Wirthlin, MD
Organizational Affiliation
Spokane Eye Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Callanan, MD
Organizational Affiliation
Texas Retina Associates in Arlington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl G. Csaky, MD, PhD
Organizational Affiliation
Texas Retina Associates in Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Surendar Purohit, MD
Organizational Affiliation
TLC Eye Care & Laser Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor H. Gonzalez, MD
Organizational Affiliation
Valley Retina Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louis Glazer, MD
Organizational Affiliation
Vitreo-Retinal Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean Eliott, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanley M Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5540
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)

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