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. mars 2017 oppdatert av: 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 .
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
205
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Makati City, Filippinene, 1209
- Novartis Investigative Site
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Pasig City, Filippinene, 1605
- Novartis Investigative Site
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Quezon City, Filippinene, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 navn:
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2014
Primær fullføring (Faktiske)
1. september 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
14. november 2013
Først innsendt som oppfylte QC-kriteriene
14. november 2013
Først lagt ut (Anslag)
20. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRFB002A-MAX-IL-01
- 2013-003482-34 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .