- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02251366
NVAMD Satellite Study
A Multi-Satellite Comparison of Standard-of-Care, Physician-Based Retinal Evaluation Versus Physician-Guided Diagnostic Evaluation in the Management of Neovascular Age-Related Macular Degeneration With Anti-Vascular Endothelial Growth Factor Therapy
Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has revolutionized the management of neovascular age-related macular degeneration (NVAMD). However, the requirement for near monthly administration of therapy coupled with the growing number of patients needing treatment has become a universal challenge in efficient delivery of care for retina physicians. While many retina practices have both increased the size of their staffs to accommodate the growing patient population and increased efficiency with the aid of digital photography, patient encounter times in clinic continue to increase, often spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined alternative in the evaluation of patients with NVAMD to determine whether intravitreal therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.
This multi-satellite, prospective, randomized pilot study will compare standard-of-care, physician- based retinal evaluation, defined as retinal examination by a physician and standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography (FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and optional FA without retinal examination by a physician in the management of NVAMD with anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the physician-based retinal evaluation based on measures such as a change from baseline in visual acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this study are length of visit times, numbers of intravitreal injections of anti-VEGF agents administered, numbers of diagnostic tests performed to determine whether treatment should be given at each visit, and frequency of retinal examinations performed for each participating patient in each cohort. Perceptions of quality of vision and patient satisfaction will be captured by interviews with patients following each clinic visit; clinical impressions of physicians will be captured by a brief physician survey. Finally, the feasibility of recruiting patients, as measured by how many eligible patients are seen at each Wilmer satellite, how many patients agree to be randomized, how many patients follow-up, and the attrition rates at the 4 and 8-month outcome visits will be assessed.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Bel Air, Maryland, Stati Uniti, 21014
- Wilmer Eye Institute
-
Bethesda, Maryland, Stati Uniti, 20814
- Wilmer Eye Institute
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Columbia, Maryland, Stati Uniti, 21044
- Wilmer Eye Institute
-
Frederick, Maryland, Stati Uniti, 21702
- Wilmer Eye Institute
-
Lutherville, Maryland, Stati Uniti, 21093
- Wilmer Eye Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- Established diagnosis of NVAMD in one or both eyes
- Received 2 or more intravitreal injections of anti-VEGF therapy from the retinal physician during the prior 6 months
- Need for more therapy on a near monthly basis is anticipated
- Usual corrected visual acuity (UCVA) of at least one eye must be 20/200 or better
- Must be physically able to cooperate with OCT and other diagnostic imaging procedures
- Must be able to give informed consent and be able to complete telephone surveys
Exclusion criteria:
- Systemic disease that can affect the peripheral retina (e.g., diabetes mellitus, sickle cell)
- History of symptomatic posterior vitreous detachment, retinal tear, or retinal detachment
- History of retinal surgery will not be enrolled.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: SOC Examination Based Cohort
Participants in this arm will receive standard of care (SOC) retinal examinations at each study visit.
|
|
Comparatore attivo: Physician-Guided Diagnostic
Participants in this arm of the study will only receive the physical standard-of-care retinal examination at the 4-month and -month office visits, unless requested by the Physician-Investigator or study participant.
At each standard study visit, the physician will use diagnostic imaging to determine if the participant will receive the anti-VEGF injection.
|
NVAMD participants in the physician-guided diagnostic arm will have receive injections based on diagnostic imaging provided by optical coherence tomography and optional fluorescein angiography, those in this group will only receive retinal examinations at the 4- and 8-month clinic visits.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in visual acuity from baseline
Lasso di tempo: up to two years
|
up to two years
|
Change in OCT CSF from baseline
Lasso di tempo: up to two years
|
up to two years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
total encounter time for each arm
Lasso di tempo: up to two years
|
up to two years
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
---|---|
Number of intravitreal anti-VEGF injections administered
Lasso di tempo: up to two years
|
up to two years
|
number of diagnostic tests performed
Lasso di tempo: up to two years
|
up to two years
|
number of retinal examinations performed
Lasso di tempo: up to two years
|
up to two years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sharon Solomon, MD, Johns Hopkins University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NA_00088759
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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