Clinical trial NCT01565148: 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)
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema (DME)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: iCo Therapeutics Inc.
First posted: 2012-03-28
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in VA From Baseline to Month 8
timeFrame: Baseline to month 8
Secondary outcomes:
measure: Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
timeFrame: Baseline to month 8
measure: Change in VA From Baseline to Month 12
timeFrame: Baseline to month 12
measure: Change in Retinal Thickness Measured by OCT From Baseline to Month 8
timeFrame: Baseline to month 8
measure: Change in Retinal Thickness Measured
timeFrame: Baseline to month 12
measure: Duration of iCo-007 Treatment Effect
timeFrame: Baseline to month 12
measure: Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
timeFrame: Baseline to month 12
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Stanley M Truhlsen Eye Institute
state: Nebraska
Study officials:
affiliation: Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
name: Diana V. Do, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Retina Associates
name: Robert Wong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Retina Macula Disease
name: Michael J. Tolentino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Black Hills Regional Eye Institute
name: Prema Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Bay Retina Institute
name: Eugene Lit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elman Retina Group
name: Michael J. Elman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Retina Institute
name: Thomas A. Barnard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Eye Institute
name: Thomas A. Ciulla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Eye and Ear Infirmary
name: Richard B. Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Centers, P.C.
name: Henry L. Hudson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Consultants of Arizona
name: Pravin Dugel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Consultants of Hawaii, Pali Momi Medical Center
name: Gregg T. Kokame, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Consultants Houston
name: David M. Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Group of Florida
name: Larry S. Halperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Institute of Hawaii
name: Goergios Papastergio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Macula Institute
name: Ron P. Gallemore, MD. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Research Center
name: Brian B. Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina Vitreous Associates
name: Homayoun Tabandeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeast Retina
name: Dennis M. Marcus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spokane Eye Clinic
name: Robert S. Wirthlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Retina Associates in Arlington
name: David Callanan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Retina Associates in Dallas
name: Karl G. Csaky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TLC Eye Care & Laser Center
name: Surendar Purohit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley Retina Institute
name: Victor H. Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vitreo-Retinal Associates
name: Louis Glazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Eye and Ear Infirmary, Harvard Medical School
name: Dean Eliott, MD
role: PRINCIPAL_INVESTIGATOR
References: