UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD) (UNRAVEL)
30. marts 2017 opdateret af: Novartis Pharmaceuticals
A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment naïve Neovascular Age-related Macular Degeneration (nAMD) Patients
This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.
Free plasma VEGF-A level was measured in this study .
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
205
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Makati City, Filippinerne, 1209
- Novartis Investigative Site
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Pasig City, Filippinerne, 1605
- Novartis Investigative Site
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Quezon City, Filippinerne, 1102
- Novartis Investigative Site
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Be'er Sheva, Israel, 84101
- Novartis Investigative Site
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Haifa, Israel, 3525408
- Novartis Investigative Site
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Haifa, Israel, 3436212
- Novartis Investigative Site
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Kfar-Saba, Israel, 4428164
- Novartis Investigative Site
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Petach Tikva, Israel, 49100
- Novartis Investigative Site
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Rehovot, Israel, 7610001
- Novartis Investigative Site
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Tel Aviv, Israel, 6423906
- Novartis Investigative Site
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Daegu, Korea, Republikken, 705-703
- Novartis Investigative Site
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Seoul, Korea, Republikken, 150-950
- Novartis Investigative Site
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Seoul, Korea, Republikken, 06273
- Novartis Investigative Site
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Korea
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Seoul, Korea, Korea, Republikken, 05505
- Novartis Investigative Site
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Seoul, Korea, Korea, Republikken, 03722
- Novartis Investigative Site
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Kuala Lumpur, Malaysia, 59200
- Novartis Investigative Site
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Selangor Darul Ehsan
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Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46200
- Novartis Investigative Site
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Singapore, Singapore, 117549
- Novartis Investigative Site
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Singapore, Singapore, 574623
- Novartis Investigative Site
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Lin-Kou, Taiwan, 33305
- Novartis Investigative Site
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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Bangkok, Thailand, 10330
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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Bangkoknoi
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Bangkok, Bangkoknoi, Thailand, 10700
- Novartis Investigative Site
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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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria
- Newly diagnosed Age-related Macular Degeneration (AMD)
- No previous treatment received for diagnosed AMD
- Visual Acuity 6/7.5 to 6/96
Key Exclusion Criteria:
- standard exclusion criteria for anti-VEGF treatment
- Visual Acuity <6/96
- nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
- other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
- participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT.
0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician.
3 injections were performed (Baseline, Month 1, Month 2).
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Blood measurement
Andre navne:
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Aktiv komparator: Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT.
2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician.
3 injections were performed (Baseline, Month 1, Month 2).
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Blood measurement
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
Tidsramme: Change from baseline at Month 3
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Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
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Change from baseline at Month 3
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percent Change From Baseline in Plasma VEGF Level Overtime
Tidsramme: Change from baseline up to month 3
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Plasma VEGF measurement performed at all visits and compared to baseline level
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Change from baseline up to month 3
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Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Tidsramme: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
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VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.
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pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
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Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Tidsramme: Baseline, month 1, month 2, month 3
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BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters.
An increase in score indicates an improvement in acuity.
Change from baseline calculated as observed post-baseline value - baseline value.
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Baseline, month 1, month 2, month 3
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Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Tidsramme: Baseline, month 1, month 2, month 3
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CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area. Change from baseline calculated as observed post-baseline - baseline value. |
Baseline, month 1, month 2, month 3
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Number of Patients With Ocular and Systemic Adverse Events
Tidsramme: Day 1 to day 85
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The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).
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Day 1 to day 85
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. april 2014
Primær færdiggørelse (Faktiske)
1. september 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
14. november 2013
Først indsendt, der opfyldte QC-kriterier
14. november 2013
Først opslået (Skøn)
20. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRFB002A-MAX-IL-01
- 2013-003482-34 (EudraCT nummer)
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 .