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Trial record 2 of 2 for:    iCo-007

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)

This study has been terminated.
(Patient's disease progressed and Vision Dropped which led to exit from the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01565148
First Posted: March 28, 2012
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Juvenile Diabetes Research Foundation
iCo Therapeutics Inc.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: October 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: iCo-007 350 mcg
Drug: iCo-007 700 mcg
Drug: iCo-007 350 mcg and Laser
Drug: Ranibizumab and iCo-007 350 mcg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
iCo-007 350 mcg 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
iCo-007 700 mcg 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
iCo-007 350 mcg and Laser 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
Ranibizumab and iCo-007 350 mcg Ranibizumab Plus 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

Participant Flow:   Overall Study
    iCo-007 350 mcg   iCo-007 700 mcg   iCo-007 350 mcg and Laser   Ranibizumab and iCo-007 350 mcg
STARTED   47   46   47   45 
COMPLETED   32   31   40   32 
NOT COMPLETED   15   15   7   13 
Withdrawal by Subject                1                1                1                2 
Lost to Follow-up                4                4                0                3 
Rescue Therapy                8                5                5                8 
Death                0                0                1                0 
Physician Decision                2                5                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 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
Group 2 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
Group 3 iCo-007 350 mcg Plus 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
Group 4 Ranibizumab Plus 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
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   46   47   45   185 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (8.91)   62.8  (9.7)   61.4  (9.72)   61.2  (7.29)   62.2  (8.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      27  57.4%      19  41.3%      20  42.6%      17  37.8%      83  44.9% 
Male      20  42.6%      27  58.7%      27  57.4%      28  62.2%      102  55.1% 
Baseline Best Corrected Visual Acuity (BCVA) 
[Units: Letters]
Mean (Standard Deviation)
 57.9  (12.3)   58.7  (12.49)   59.8  (13.78)   61.5  (14.03)   59.3  (13.15) 


  Outcome Measures
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1.  Primary:   Change in VA From Baseline to Month 8   [ Time Frame: Baseline to month 8 ]

2.  Secondary:   Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability   [ Time Frame: Baseline to month 8 ]

3.  Secondary:   Change in VA From Baseline to Month 12   [ Time Frame: Baseline to month 12 ]

4.  Secondary:   Change in Retinal Thickness Measured by OCT From Baseline to Month 8   [ Time Frame: Baseline to month 8 ]

5.  Secondary:   Change in Retinal Thickness Measured   [ Time Frame: Baseline to month 12 ]

6.  Secondary:   Duration of iCo-007 Treatment Effect   [ Time Frame: Baseline to month 12 ]

7.  Secondary:   Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections   [ Time Frame: Baseline to month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Quan Dong Nguyen
Organization: University of Nebraska
phone: 4025592020
e-mail: quan.nguyen@unmc.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01565148     History of Changes
Other Study ID Numbers: 2010-007-03-DME
First Submitted: March 15, 2012
First Posted: March 28, 2012
Results First Submitted: October 11, 2016
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017