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)

NCT01565148 | Terminated Phase 2 Results DMC

• 1 other identifier: 2010-007-03-DME
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to month 8

Secondary Outcomes (6)

• Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability

  Baseline to month 8

• Change in VA From Baseline to Month 12

  Baseline to month 12

• Change in Retinal Thickness Measured by OCT From Baseline to Month 8

  Baseline to month 8

• Change in Retinal Thickness Measured

  Baseline to month 12

• Duration of iCo-007 Treatment Effect

  Baseline to month 12

Study Arms (4)

Group 1

EXPERIMENTAL

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-007 350 mcg

Group 2

EXPERIMENTAL

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-007 700 mcg

Group 3

EXPERIMENTAL

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: iCo-007 350 mcg and Laser

Group 4

EXPERIMENTAL

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

Drug: Ranibizumab and iCo-007 350 mcg

Interventions

iCo-007 350 mcg DRUG

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

Also known as: Group 1

Group 1

iCo-007 700 mcg DRUG

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

Also known as: Group 2

Group 2

iCo-007 350 mcg and Laser DRUG

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

Also known as: Group 3

Group 3

Ranibizumab and iCo-007 350 mcg DRUG

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

Also known as: Group 4

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• /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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Juvenile Diabetes Research Foundation: collaborator
• iCo Therapeutics Inc.: collaborator

Study Sites (1)

Stanley M Truhlsen Eye Institute

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Interventions

Lasers; Ranibizumab

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Quan Dong Nguyen
• Organization: University of Nebraska

quan.nguyen@unmc.edu

4025592020

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Dean Eliott, MD

  Massachusetts Eye and Ear Infirmary, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 28, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (1)