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 uppdaterad 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 .
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
205
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Makati City, Filippinerna, 1209
- Novartis Investigative Site
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Pasig City, Filippinerna, 1605
- Novartis Investigative Site
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Quezon City, Filippinerna, 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, Republiken av, 705-703
- Novartis Investigative Site
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Seoul, Korea, Republiken av, 150-950
- Novartis Investigative Site
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Seoul, Korea, Republiken av, 06273
- Novartis Investigative Site
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Korea
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Seoul, Korea, Korea, Republiken av, 05505
- Novartis Investigative Site
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Seoul, Korea, Korea, Republiken av, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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
Andra namn:
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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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percent Change From Baseline in Plasma VEGF Level Overtime
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
14 november 2013
Först inskickad som uppfyllde QC-kriterierna
14 november 2013
Första postat (Uppskatta)
20 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRFB002A-MAX-IL-01
- 2013-003482-34 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .