- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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) (iDEAL)
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 optical coherence tomography (OCT) from baseline to month 8 and month 12
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198-5540
- Stanley M Truhlsen Eye Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group 1
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 |
iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
Andre navne:
|
Eksperimentel: Group 2
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 |
iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
Andre navne:
|
Eksperimentel: Group 3
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 |
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
Andre navne:
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Eksperimentel: Group 4
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 |
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in VA From Baseline to Month 8
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Tidsramme: Baseline to month 8
|
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;
|
Baseline to month 8
|
Change in VA From Baseline to Month 12
Tidsramme: 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
|
Baseline to month 12
|
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Tidsramme: Baseline to month 8
|
Group 1
|
Baseline to month 8
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Change in Retinal Thickness Measured
Tidsramme: Baseline to month 12
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measured by OCT
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Baseline to month 12
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Duration of iCo-007 Treatment Effect
Tidsramme: Baseline to month 12
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treatment effect as measured by VA and OCY thickness
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Baseline to month 12
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Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
Tidsramme: Baseline to month 12
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cmax
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Baseline to month 12
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Diana V. Do, MD, Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- Ledende efterforsker: Robert Wong, MD, Austin Retina Associates
- Ledende efterforsker: Michael J. Tolentino, MD, Center for Retina Macula Disease
- Ledende efterforsker: Prema Abraham, MD, Black Hills Regional Eye Institute
- Ledende efterforsker: Eugene Lit, MD, East Bay Retina Institute
- Ledende efterforsker: Michael J. Elman, MD, Elman Retina Group
- Ledende efterforsker: Thomas A. Barnard, MD, Florida Retina Institute
- Ledende efterforsker: Thomas A. Ciulla, MD, Midwest Eye Institute
- Ledende efterforsker: Richard B. Rosen, MD, New York Eye and Ear Infirmary
- Ledende efterforsker: Henry L. Hudson, MD, Retina Centers, P.C.
- Ledende efterforsker: Pravin Dugel, MD, Retina Consultants of Arizona
- Ledende efterforsker: Gregg T. Kokame, MD, Retina Consultants of Hawaii, Pali Momi Medical Center
- Ledende efterforsker: David M. Brown, MD, Retina Consultants Houston
- Ledende efterforsker: Larry S. Halperin, MD, Retina Group of Florida
- Ledende efterforsker: Goergios Papastergio, MD, Retina Institute of Hawaii
- Ledende efterforsker: Ron P. Gallemore, MD. PhD, Retina Macula Institute
- Ledende efterforsker: Brian B. Berger, MD, Retina Research Center
- Ledende efterforsker: Homayoun Tabandeh, MD, Retina Vitreous Associates
- Ledende efterforsker: Dennis M. Marcus, MD, Southeast Retina
- Ledende efterforsker: Robert S. Wirthlin, MD, Spokane Eye Clinic
- Ledende efterforsker: David Callanan, MD, Texas Retina Associates in Arlington
- Ledende efterforsker: Karl G. Csaky, MD, PhD, Texas Retina Associates in Dallas
- Ledende efterforsker: Surendar Purohit, MD, TLC Eye Care & Laser Center
- Ledende efterforsker: Victor H. Gonzalez, MD, Valley Retina Institute
- Ledende efterforsker: Louis Glazer, MD, Vitreo-Retinal Associates
- Ledende efterforsker: Dean Eliott, MD, Massachusetts Eye and Ear Infirmary, Harvard Medical School
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010-007-03-DME
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