- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
-
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68198-5540
- Stanley M Truhlsen Eye Institute
-
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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
Muut nimet:
|
Kokeellinen: 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
Muut nimet:
|
Kokeellinen: 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
Muut nimet:
|
Kokeellinen: 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
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Change in VA From Baseline to Month 8
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline to month 8
|
Group 1
|
Baseline to month 8
|
Change in Retinal Thickness Measured
Aikaikkuna: Baseline to month 12
|
measured by OCT
|
Baseline to month 12
|
Duration of iCo-007 Treatment Effect
Aikaikkuna: Baseline to month 12
|
treatment effect as measured by VA and OCY thickness
|
Baseline to month 12
|
Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
Aikaikkuna: Baseline to month 12
|
cmax
|
Baseline to month 12
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Diana V. Do, MD, Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- Päätutkija: Robert Wong, MD, Austin Retina Associates
- Päätutkija: Michael J. Tolentino, MD, Center for Retina Macula Disease
- Päätutkija: Prema Abraham, MD, Black Hills Regional Eye Institute
- Päätutkija: Eugene Lit, MD, East Bay Retina Institute
- Päätutkija: Michael J. Elman, MD, Elman Retina Group
- Päätutkija: Thomas A. Barnard, MD, Florida Retina Institute
- Päätutkija: Thomas A. Ciulla, MD, Midwest Eye Institute
- Päätutkija: Richard B. Rosen, MD, New York Eye and Ear Infirmary
- Päätutkija: Henry L. Hudson, MD, Retina Centers, P.C.
- Päätutkija: Pravin Dugel, MD, Retina Consultants of Arizona
- Päätutkija: Gregg T. Kokame, MD, Retina Consultants of Hawaii, Pali Momi Medical Center
- Päätutkija: David M. Brown, MD, Retina Consultants Houston
- Päätutkija: Larry S. Halperin, MD, Retina Group of Florida
- Päätutkija: Goergios Papastergio, MD, Retina Institute of Hawaii
- Päätutkija: Ron P. Gallemore, MD. PhD, Retina Macula Institute
- Päätutkija: Brian B. Berger, MD, Retina Research Center
- Päätutkija: Homayoun Tabandeh, MD, Retina Vitreous Associates
- Päätutkija: Dennis M. Marcus, MD, Southeast Retina
- Päätutkija: Robert S. Wirthlin, MD, Spokane Eye Clinic
- Päätutkija: David Callanan, MD, Texas Retina Associates in Arlington
- Päätutkija: Karl G. Csaky, MD, PhD, Texas Retina Associates in Dallas
- Päätutkija: Surendar Purohit, MD, TLC Eye Care & Laser Center
- Päätutkija: Victor H. Gonzalez, MD, Valley Retina Institute
- Päätutkija: Louis Glazer, MD, Vitreo-Retinal Associates
- Päätutkija: Dean Eliott, MD, Massachusetts Eye and Ear Infirmary, Harvard Medical School
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2010-007-03-DME
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