Back to Search
Start Over
Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR
- Source :
- Trials, 21, Trials, 21, 1, Trials, Trials, Vol 21, Iss 1, Pp 1-11 (2020)
- Publication Year :
- 2020
-
Abstract
- BackgroundThere is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials.MethodsThe protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part’s primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part’s primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from iAMD to late AMD. All data will be used to support a biomarker qualification procedure by regulatory authorities.DiscussionThe MACUSTAR study characterizes and evaluates much needed novel functional, structural, and patient-reported endpoints for future clinical trials in iAMD and will improve our understanding of the natural history and prognostic markers of this condition.Trial registrationClinicalTrials.govNCT03349801. Registered on 22 November 2017
- Subjects :
- medicine.medical_specialty
Endpoint Determination
Psychological intervention
Medicine (miscellaneous)
Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12]
Clinical study
Macular Degeneration
Study Protocol
03 medical and health sciences
0302 clinical medicine
All institutes and research themes of the Radboud University Medical Center
medicine
Clinical endpoint
Humans
Multicenter Studies as Topic
Pharmacology (medical)
Longitudinal Studies
Intensive care medicine
030304 developmental biology
Protocol (science)
Clinical Trials as Topic
0303 health sciences
Disease progression
lcsh:R5-920
business.industry
Macular degeneration
medicine.disease
3. Good health
Biomarker (cell)
Clinical trial
Natural history
Observational Studies as Topic
Cross-Sectional Studies
Research Design
030221 ophthalmology & optometry
RE
Intermediate age-related macular degeneration
Clinical study protocol
business
lcsh:Medicine (General)
Tomography, Optical Coherence
Subjects
Details
- ISSN :
- 17456215
- Database :
- OpenAIRE
- Journal :
- Trials, 21, Trials, 21, 1, Trials, Trials, Vol 21, Iss 1, Pp 1-11 (2020)
- Accession number :
- edsair.doi.dedup.....e0f9cd37296418f935efd3094ac7e1f7