- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Nebraska
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Omaha, Nebraska, États-Unis, 68198-5540
- Stanley M Truhlsen Eye Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
Autres noms:
|
Expérimental: 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
Autres noms:
|
Expérimental: 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
Autres noms:
|
Expérimental: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in VA From Baseline to Month 8
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Délai: Baseline to month 8
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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;
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Baseline to month 8
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Change in VA From Baseline to Month 12
Délai: Baseline to month 12
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The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
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Baseline to month 12
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Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Délai: Baseline to month 8
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Group 1
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Baseline to month 8
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Change in Retinal Thickness Measured
Délai: 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
Délai: 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
Délai: Baseline to month 12
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cmax
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Baseline to month 12
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Diana V. Do, MD, Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- Chercheur principal: Robert Wong, MD, Austin Retina Associates
- Chercheur principal: Michael J. Tolentino, MD, Center for Retina Macula Disease
- Chercheur principal: Prema Abraham, MD, Black Hills Regional Eye Institute
- Chercheur principal: Eugene Lit, MD, East Bay Retina Institute
- Chercheur principal: Michael J. Elman, MD, Elman Retina Group
- Chercheur principal: Thomas A. Barnard, MD, Florida Retina Institute
- Chercheur principal: Thomas A. Ciulla, MD, Midwest Eye Institute
- Chercheur principal: Richard B. Rosen, MD, New York Eye and Ear Infirmary
- Chercheur principal: Henry L. Hudson, MD, Retina Centers, P.C.
- Chercheur principal: Pravin Dugel, MD, Retina Consultants of Arizona
- Chercheur principal: Gregg T. Kokame, MD, Retina Consultants of Hawaii, Pali Momi Medical Center
- Chercheur principal: David M. Brown, MD, Retina Consultants Houston
- Chercheur principal: Larry S. Halperin, MD, Retina Group of Florida
- Chercheur principal: Goergios Papastergio, MD, Retina Institute of Hawaii
- Chercheur principal: Ron P. Gallemore, MD. PhD, Retina Macula Institute
- Chercheur principal: Brian B. Berger, MD, Retina Research Center
- Chercheur principal: Homayoun Tabandeh, MD, Retina Vitreous Associates
- Chercheur principal: Dennis M. Marcus, MD, Southeast Retina
- Chercheur principal: Robert S. Wirthlin, MD, Spokane Eye Clinic
- Chercheur principal: David Callanan, MD, Texas Retina Associates in Arlington
- Chercheur principal: Karl G. Csaky, MD, PhD, Texas Retina Associates in Dallas
- Chercheur principal: Surendar Purohit, MD, TLC Eye Care & Laser Center
- Chercheur principal: Victor H. Gonzalez, MD, Valley Retina Institute
- Chercheur principal: Louis Glazer, MD, Vitreo-Retinal Associates
- Chercheur principal: Dean Eliott, MD, Massachusetts Eye and Ear Infirmary, Harvard Medical School
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies oculaires
- Dégénérescence rétinienne
- Maladies rétiniennes
- Dégénérescence maculaire
- Œdème maculaire
- Œdème
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Ranibizumab
Autres numéros d'identification d'étude
- 2010-007-03-DME
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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