- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01003106
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions (RELATE)
16. februar 2016 opdateret af: Peter A Campochiaro, MD
RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6.
At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared.
Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
81
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Wilmer Eye Institute at Johns Hopkins University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age equal to or greater than 18 years
- Diagnosis of macular edema due to central or branch retinal vein occlusion
- Foveal thickness of equal to or greater than 250 mm, as assessed by OCT
- Best corrected visual acuity score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled.
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
Exclusion Criteria:
- Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Intraocular surgery in the study eye within 3 months of study entry
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
- Previous use of an anti-VEGF drug within 3 months of study entry
- Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
- History of vitreoretinal surgery in the study eye within 3 months of study entry
- Uncontrolled glaucoma (defined as intraocular pressure ³30 mm Hg despite treatment with anti-glaucoma medications)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Have the presence of active malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
- History of allergy to humanized antibodies or any component of the ranibizumab formulation
- Inability to comply with study or followup procedures
- Participation in another simultaneous medical investigation or trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: BRVO- Ranibizumab 0.5mg alone
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
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Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
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Eksperimentel: BRVO- Pro re nata (prn) ranibizumab with laser
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
|
|
|
Eksperimentel: BRVO- Ranibizumab 2.0mg alone
Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
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|
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Eksperimentel: BRVO- Pro re nata (prn) ranibizumab
Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
|
|
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Eksperimentel: CRVO- Ranibizumab 0.5mg alone
Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
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Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
|
|
Eksperimentel: CRVO- Pro re nata (prn) ranibizumab with laser
Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
|
|
|
Eksperimentel: CRVO- Ranibizumab 2.0mg alone
Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
|
|
|
Eksperimentel: CRVO- Pro re nata (prn) ranibizumab
Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence and Severity of Ocular and Non-ocular Adverse Events.
Tidsramme: 36 months
|
36 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Tidsramme: Baseline to month 6
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Baseline to month 6
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Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
Tidsramme: Month 6- Month 36
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Month 6- Month 36
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Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab
Tidsramme: Baseline to month 6
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Baseline to month 6
|
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Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.
Tidsramme: Month 6- Month 36
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Month 6- Month 36
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. april 2015
Datoer for studieregistrering
Først indsendt
26. oktober 2009
Først indsendt, der opfyldte QC-kriterier
27. oktober 2009
Først opslået (Skøn)
28. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NA_00032394
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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