A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD
Studieöversikt
Detaljerad beskrivning
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The advanced stages of the disease are characterized by the development of geographic atrophy or choroidal neovascularization, both of which result in significant loss of vision. Development of intravitreal anti-VEGF agents such as ranibizumab has significantly improved outcomes for the neovascular for of the disease. However, it is not possible to predict which individuals will respond to the treatment.
The objective of this study is to establish the association between genetic factors and treatment response to intravitreal Lucentis. This will be accomplished by SNP-genotyping participants for AMD-susceptibility and candidate angiogenesis-pathway genes, collecting environmental risk factor variables and evaluating clinical outcomes. The aim of this pharmacogenetics study will be to identify patients at the outset of their treatment that require more intensive therapy.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Oregon
-
Portland, Oregon, Förenta staterna, 97239
- Casey Eye Institute, Oregon Health and Science University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- All AMD-related CNV lesion types will be included.
- Age >50 years
- The study eye must never have received treatment for neovascular AMD
- Visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS).
Exclusion Criteria:
- Age <50 years;
- Previous therapy in either eye for AMD or other retinal disease which may be used in the treatment of AMD;
- Choroidal neovascularization not from AMD;
- Concomitant non-AMD related maculopathy in study eye;
- Active treatment for neovascular AMD in fellow eye;
- Acuity loss or central field loss from non-AMD cause;
- Pigment epithelial detachment without evidence of CNV;
- Individuals in whom Lucentis is contraindicated;
- Participation in another clinical trial in last three months
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression'
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype
Tidsram: 12 months
|
12 months
|
|
Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.
Tidsram: 12 months
|
12 months
|
|
Median number of intravitreal ranibizumab (Lucentis) injections required per patient
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Peter J Francis, MD PhD, Casey Eye Institute, Oregon Health and Science University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00003335
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 .