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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
iCo Therapeutics Inc.
Information provided by (Responsible Party):
Quan Dong Nguyen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01565148
First received: March 15, 2012
Last updated: June 24, 2013
Last verified: June 2013

March 15, 2012
June 24, 2013
February 2012
September 2013   (final data collection date for primary outcome measure)
Change in VA from baseline to month 8 [ Time Frame: Baseline to month 8 ] [ Designated as safety issue: No ]
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
Same as current
Complete list of historical versions of study NCT01565148 on ClinicalTrials.gov Archive Site
  • 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 12 ] [ Designated as safety issue: Yes ]
    Safety of repeated iCo-007 intravitreal injections in treatment of subjects with 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 [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Change in retinal thickness measured by OCT from baseline to month 8 [ Time Frame: Baseline to month 8 ] [ Designated as safety issue: No ]
  • Change in retinal thickness measured by OCT from baseline to month 12 [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Duration of iCo-007 treatment effect during the 12 month follow-up period as measured by VA and OCt thickness [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax)of iCo-007 after multiple injections [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • 2 or more patients in a given study arm experiencing the same drug-related SAE [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: Yes ]
    Safety of repeated iCo-007 intravitreal injections in treatment of subjects with 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 [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Change in retinal thickness measured by OCT from baseline to month 8 [ Time Frame: Baseline to month 8 ] [ Designated as safety issue: No ]
  • Change in retinal thickness measured by OCT from baseline to month 12 [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Duration of iCo-007 treatment effect during the 12 month follow-up period as measured by VA and OCt thickness [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax)of iCo-007 after multiple injections [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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)
  • 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 OCT from baseline to month 8 and month 12
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
  • 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
    Other Name: Group 1
  • 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
    Other Name: Group 2
  • Drug: 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
    Other Name: Group 3
  • Drug: 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
    Other Name: Group 4
  • Experimental: Group 1
    Intervention: Drug: iCo-007 350 mcg
  • Experimental: Group 2
    Intervention: Drug: iCo-007 700 mcg
  • Experimental: Group 3
    Intervention: Drug: iCo-007 350 mcg Plus Laser
  • Experimental: Group 4
    Intervention: Drug: Ranibizumab Plus iCo-007 350 mcg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
208
December 2013
September 2013   (final data collection date for primary outcome measure)

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 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 AST, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01565148
2010-007-03-DME
Yes
Quan Dong Nguyen, Johns Hopkins University
Quan Dong Nguyen
  • Juvenile Diabetes Research Foundation
  • iCo Therapeutics Inc.
Principal Investigator: Diana V. Do, MD Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
Principal Investigator: Robert Wong, MD Austin Retina Associates
Principal Investigator: Michael J. Tolentino, MD Center for Retina Macula Disease
Principal Investigator: Prema Abraham, MD Black Hills Regional Eye Institute
Principal Investigator: Eugene Lit, MD East Bay Retina Institute
Principal Investigator: Michael J. Elman, MD Elman Retina Group
Principal Investigator: Thomas A. Barnard, MD Florida Retina Institute
Principal Investigator: Thomas A. Ciulla, MD Midwest Eye Institute
Principal Investigator: Richard B. Rosen, MD New York Eye and Ear Infirmary
Principal Investigator: Henry L. Hudson, MD Retina Centers, P.C.
Principal Investigator: Pravin Dugel, MD Retina Consultants of Arizona
Principal Investigator: Gregg T. Kokame, MD Retina Consultants of Hawaii, Pali Momi Medical Center
Principal Investigator: David M. Brown, MD Retina Consultants Houston
Principal Investigator: Larry S. Halperin, MD Retina Group of Florida
Principal Investigator: Goergios Papastergio, MD Retina Institute of Hawaii
Principal Investigator: Ron P. Gallemore, MD. PhD Retina Macula Institute
Principal Investigator: Brian B. Berger, MD Retina Research Center
Principal Investigator: Homayoun Tabandeh, MD Retina Vitreous Associates
Principal Investigator: Dennis M. Marcus, MD Southeast Retina
Principal Investigator: Robert S. Wirthlin, MD Spokane Eye Clinic
Principal Investigator: David Callanan, MD Texas Retina Associates in Arlington
Principal Investigator: Karl G. Csaky, MD, PhD Texas Retina Associates in Dallas
Principal Investigator: Surendar Purohit, MD TLC Eye Care & Laser Center
Principal Investigator: Victor H. Gonzalez, MD Valley Retina Institute
Principal Investigator: Louis Glazer, MD Vitreo-Retinal Associates
Johns Hopkins University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP