- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
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Nebraska
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Omaha, Nebraska, Spojené státy, 68198-5540
- Stanley M Truhlsen Eye Institute
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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
Ostatní jména:
|
Experimentální: 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
Ostatní jména:
|
Experimentální: 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
Ostatní jména:
|
Experimentální: 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
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in VA From Baseline to Month 8
Časové okno: Baseline to month 8
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The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
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Baseline to month 8
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Časové okno: 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
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Change in VA From Baseline to Month 12
Časové okno: 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
Časové okno: Baseline to month 8
|
Group 1
|
Baseline to month 8
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Change in Retinal Thickness Measured
Časové okno: 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
Časové okno: 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
Časové okno: Baseline to month 12
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cmax
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Baseline to month 12
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Diana V. Do, MD, Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- Vrchní vyšetřovatel: Robert Wong, MD, Austin Retina Associates
- Vrchní vyšetřovatel: Michael J. Tolentino, MD, Center for Retina Macula Disease
- Vrchní vyšetřovatel: Prema Abraham, MD, Black Hills Regional Eye Institute
- Vrchní vyšetřovatel: Eugene Lit, MD, East Bay Retina Institute
- Vrchní vyšetřovatel: Michael J. Elman, MD, Elman Retina Group
- Vrchní vyšetřovatel: Thomas A. Barnard, MD, Florida Retina Institute
- Vrchní vyšetřovatel: Thomas A. Ciulla, MD, Midwest Eye Institute
- Vrchní vyšetřovatel: Richard B. Rosen, MD, New York Eye and Ear Infirmary
- Vrchní vyšetřovatel: Henry L. Hudson, MD, Retina Centers, P.C.
- Vrchní vyšetřovatel: Pravin Dugel, MD, Retina Consultants of Arizona
- Vrchní vyšetřovatel: Gregg T. Kokame, MD, Retina Consultants of Hawaii, Pali Momi Medical Center
- Vrchní vyšetřovatel: David M. Brown, MD, Retina Consultants Houston
- Vrchní vyšetřovatel: Larry S. Halperin, MD, Retina Group of Florida
- Vrchní vyšetřovatel: Goergios Papastergio, MD, Retina Institute of Hawaii
- Vrchní vyšetřovatel: Ron P. Gallemore, MD. PhD, Retina Macula Institute
- Vrchní vyšetřovatel: Brian B. Berger, MD, Retina Research Center
- Vrchní vyšetřovatel: Homayoun Tabandeh, MD, Retina Vitreous Associates
- Vrchní vyšetřovatel: Dennis M. Marcus, MD, Southeast Retina
- Vrchní vyšetřovatel: Robert S. Wirthlin, MD, Spokane Eye Clinic
- Vrchní vyšetřovatel: David Callanan, MD, Texas Retina Associates in Arlington
- Vrchní vyšetřovatel: Karl G. Csaky, MD, PhD, Texas Retina Associates in Dallas
- Vrchní vyšetřovatel: Surendar Purohit, MD, TLC Eye Care & Laser Center
- Vrchní vyšetřovatel: Victor H. Gonzalez, MD, Valley Retina Institute
- Vrchní vyšetřovatel: Louis Glazer, MD, Vitreo-Retinal Associates
- Vrchní vyšetřovatel: Dean Eliott, MD, Massachusetts Eye and Ear Infirmary, Harvard Medical School
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2010-007-03-DME
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